FDA 510(k) Applications for Medical Device Product Code "MQV"
(Filler, Bone Void, Calcium Compound)

FDA 510(k) Number Applicant Device Name Decision Date
K171629 ACRO Biomedical Co., Ltd. ABCcolla Bone Graft 02/01/2018
K091688 AG DIGITAL TECHNOLOGY CORP. A-GRIX RESORBABLE BONE VOID FILLER 03/02/2010
K121453 AG DIGITAL TECHNOLOGY CORP. A-GRIX TE RESORABLE BONE VOID FILLER 02/05/2013
K083279 AG DIGITAL TECHNOLOGY CORP. CALTRIX RESORBABLE BONE VOID FILLER 01/28/2009
K181342 AgNovos Healthcare USA, LLC JGH1 Bone Graft Substitute 07/19/2018
K181585 AgNovos Healthcare USA, LLC JGH1 Core Deccompression Procedure Kit 07/20/2018
K071849 ALLOSOURCE, INC. ALLOFUSE GEL AND PUTTY 12/04/2008
K103036 ALLOSOURCE, INC. ALLOFUSE PLUS 01/10/2011
K161996 Amend Surgical, Inc. 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE 02/16/2017
K050025 ANGSTROM MEDICA, INC. NANOSS BONE VOID FILLER 02/03/2005
K173008 Anika Therapeutics, Inc. SCS 17-01 12/26/2017
K071206 APATECH LTD. ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE 05/31/2007
K082575 APATECH LTD. ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES 11/25/2008
K081979 APATECH LTD. ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE 11/06/2008
K082073 APATECH LTD. ACTIFUSE FLOW BONE GRAFT SUBSTITUTE 09/11/2008
K080736 APATECH LTD. ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE 04/16/2008
K033722 APATECH LTD. APAPORE BONE GRAFT SUBSTITUTE 05/07/2004
K040082 APATECH LTD. PORE-SI BONE GRAFT SUBSTITUTE 08/04/2004
K040381 ARTHREX, INC. HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 05/12/2004
K141189 ARTOSS GMBH NANOBONE / GRANULATE 01/30/2015
K161351 ARTOSS GMBH NanoBone SBX Putty 10/26/2016
K031319 ASPINE USA, INC. OSTEO-G BONE VOID FILLER SYSTEM 07/17/2003
K111018 ATPAC MEDICAL LLC POLYFUSE - NEUROBONE 02/14/2012
K091321 BACTERIN INTERNATIONAL INC. OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY 09/11/2009
K150621 BACTERIN INTERNATIONAL INC. OsteoSelect PLUS Demineralized Bone Matrix Putty 08/18/2015
K081717 BAXTER HEALTHCARE CORP. TRICOS A RESORBABLE BONE SUBSTITUTE 10/10/2008
K051722 BAXTER HEALTHCARE CORP. TRICOS T 11/18/2005
K130531 BAXTER HEALTHCARE CORP. ULTRAFUSE 04/08/2014
K181306 Baxter Healthcare Corporation Actifuse Flow 08/17/2018
K181225 Baxter Healthcare Corporation ALTAPORE 08/31/2018
K141725 BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L BONGOLD BONE GRAFT MATERIAL 07/09/2015
K170917 Berkeley Advanced Biomaterials Bi-Ostetic Bioactive Glass Foam 10/30/2017
K091912 BERKELEY ADVANCED BIOMATERIALS, INC. B-GENIN AND R-GENIN 06/23/2010
K113791 BERKELEY ADVANCED BIOMATERIALS, INC. B-GENIN, R-GENIN 03/15/2012
K023703 BERKELEY ADVANCED BIOMATERIALS, INC. BI-OSTETIC 01/30/2003
K092046 BERKELEY ADVANCED BIOMATERIALS, INC. BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY 03/24/2010
K053213 BERKELEY ADVANCED BIOMATERIALS, INC. BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM 07/06/2006
K042636 BERKELEY ADVANCED BIOMATERIALS, INC. BIOPLUS 12/14/2004
K030266 BERKELEY ADVANCED BIOMATERIALS, INC. CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ 02/20/2003
K040405 BERKELEY ADVANCED BIOMATERIALS, INC. CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY 03/05/2004
K022622 BERKELEY ADVANCED BIOMATERIALS, INC. CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P 01/09/2003
K051914 BERKELEY ADVANCED BIOMATERIALS, INC. GENEROS 80, GENEROS 60 11/03/2005
K050666 BERKELEY ADVANCED BIOMATERIALS, INC. GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES 04/11/2005
K051695 BERKELEY ADVANCED BIOMATERIALS, INC. MARROW PLUS (M+) 07/19/2005
K041889 BERKELEY ADVANCED BIOMATERIALS, INC. TRI-OSTETIC 08/19/2004
K152589 Bio2 Technologies, Inc Bio2 CLM BG Bioactive Scaffold 01/12/2016
K142463 Bio2 Technologies, Inc. Bio2 CLM BG Bioactive Scaffold 12/18/2014
K043514 BIOCOMPOSITES LTD. ALLOGRAN-N-BONE VOID FILLER 01/21/2005
K061311 BIOCOMPOSITES LTD. ALLOGRAN-R 09/22/2006
K082381 BIOCOMPOSITES LTD. GENEX 11/14/2008
K040600 BIOCOMPOSITES LTD. GENEX BONE GRAFT SUBSTITUTE 05/07/2004
K073341 BIOCOMPOSITES LTD. GENEX PUTTY 07/09/2008
K021551 BIOCOMPOSITES LTD. STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT 11/01/2002
K003954 BIOCOMPOSITES LTD. STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT 07/12/2001
K001724 BIOCOMPOSITES LTD. STIMULAN -CALCIUM SULFATE BONE VOID FILTER 08/04/2000
K141830 BIOCOMPOSITES LTD. STIMULAN KIT, STIMULAN RAPID CURE 01/23/2015
K973704 BIOGENERATION PROFUSION BONE VOID FILLER 04/03/1998
K031838 BIOGENERATION PROFUSION BONE VOID FILLER KIT 10/30/2003
K142828 BIOGENNIX osteoSPAN Morpheus 01/15/2015
K093342 BIOGENNIX, LLC BIOGENNIX RPC 07/29/2010
K132377 BIOGENNIX, LLC OSTEOSPAN MORPHEUS 05/20/2014
K032268 BIOMATLANTE MBCP 12/11/2003
K051774 BIOMATLANTE MBCP 01/20/2006
K063527 BIOMATLANTE MBCP+ 07/30/2007
K043005 BIOMATLANTE MODIFICATION TO MBCP 05/03/2005
K071121 BIOMATLANTE TRIBONE 80 09/11/2007
K041089 BIOMET MANUFACTURING, INC. OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM 08/31/2004
K032286 BIOMET ORTHOPEDICS, INC. CALCIGEN PSI BONE GRAFT SUBSTITUTE 11/20/2003
K013790 BIOMET ORTHOPEDICS, INC. CALCIGEN-S BONE VOID FILER 06/11/2002
K070864 BIOMET OSTEOBIOLOGICS BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER 06/01/2007
K082793 BIOMET SPINE INTERGRO DBM 04/02/2009
K033611 BIOMET, INC. CALCIGEN -NAP BONE VOID FILLER 04/27/2004
K030178 BIOMET, INC. CALCIGEN PSI BONE GRAFT SUBSTITUTE 02/26/2003
K011531 BIOMET, INC. CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER 09/06/2002
K051775 BIOMIMETIC PHARMACEUTICALS INC. OSTEOMIMETIC SYNTHETIC BONE MATRIX 09/06/2005
K092541 BIOSTRUCTURES INTERFACE 11/09/2010
K132071 BIOSTRUCTURES, LLC BIOACTIVE BONE GRAFT PUTTY 01/10/2014
K112857 BIOSTRUCTURES, LLC INTERFACE BONE VOID FILLER 12/13/2011
K160446 BioStructures, LLC MCP Bone Putty 11/07/2016
K142276 BIOSTRUCTURES, LLC MCS Bone Graft 01/16/2015
K162860 BIOVENTUS LLC MCS Bone Graft 02/13/2017
K071004 BONE SOLUTIONS, INC. OSTEOCRETE BONE VOID FILLER 05/21/2009
K051951 BONE SUPPORT AB CERAMENT BONE VOID FILLER 09/28/2005
K073316 BONESUPPORT AB CERAMENT BONE VOID FILLER, MODEL A0210 06/20/2008
K090871 BONESUPPORT AB CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 09/04/2009
K070220 CALCITEC, INC OSTEOFIX BONE VOID FILLER 04/12/2007
K050357 CAM IMPLANTS B.V. CAMCERAM TCP 04/21/2005
K180121 Cellumed Co., Ltd. Rafugen DBM 04/11/2018
K033679 CENTERPULSE SPINE-TECH, INC. COPSIOS BONE VOID FILLER (BVF) 07/07/2004
K013960 CERABIO, LLC APATIGHT HA-BONE GRAFT SUBSTITUTE 05/23/2002
K013966 CERABIO, LLC APATIGHT-TCP BONE GRAFT SUBSTITUTE 05/16/2002
K062200 COLLAGEN MATRIX, INC. COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS 02/13/2007
K052812 COLLAGEN MATRIX, INC. OSSIMEND (TM) BONE GRAFT MATERIAL 01/25/2006
K092608 COLLAGEN MATRIX, INC. SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX 05/28/2010
K100841 CURASAN AG BONEOPTIMIZER 08/19/2010
K181721 curasan AG Ceracell Ortho Foam 09/17/2018
K040216 CURASAN AG CERASORB M ORTHO 03/26/2004
K014156 CURASAN AG CERASORB ORTHO 03/18/2002
K160566 CURASAN AG Cerasorb Ortho Foam 12/02/2016
K031651 CURASAN AG MODIFICATION TO CERASORB ORTHO 08/13/2003
K102937 CYTOPHIL INC OSTEOPHIL BETA-TCP 12/27/2010
K014053 DEPUY ACROMED CONDUIT TCP GRANULES 03/08/2002
K011048 DEPUY ORTHOPAEDICS, INC. BSM BONE SUBSTITUTE MATERIAL 11/13/2001
K062495 DEPUY SPINE, INC. HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM 10/13/2006
K081758 DEPUY SPINE, INC. HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 09/03/2008
K043308 DEPUY SPINE, INC. MODIFICATION TO: HEALOS BONE GRAFT MATERIAL 02/16/2005
K171161 Dimensional Bioceramics LLC Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) 09/25/2017
K011386 EBI, L.P. EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE 08/03/2001
K063346 EBI, L.P. PRO OSTEON 500R 04/18/2007
K090401 ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE ORTHOSS 01/08/2010
K180853 Elute, Inc. EP GranulesÖ BVF 08/06/2018
K982663 ENCORE ORTHOPEDICS, INC. STIMULAN- CALCIUM SULFATE BONE VOID FILLER 02/26/1999
K072636 ETEX CORP. A-BSM BONE SUBSTITUTE MATERIAL 10/23/2007
K091607 ETEX CORP. ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE 11/02/2009
K063050 ETEX CORP. CAP PLUS 11/19/2007
K033138 ETEX CORP. CAP3 BONE SUBSTITUTE MATERIAL 12/02/2003
K093447 ETEX CORP. CARRIGEN 02/18/2010
K090310 ETEX CORP. EQUIVABONE 03/24/2009
K090855 ETEX CORP. EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE 09/18/2009
K090242 ETEX CORP. GAMMA-BSM, BETA-BSM 02/20/2009
K101557 ETEX CORP. GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN 07/01/2010
K072355 ETEX CORP. OSSIFUSE BONE SUBSTITUTE MATERIAL 09/26/2007
K062630 ETEX CORP. OSSIPRO BONE SUBSTITUTE MATERIAL 06/28/2007
K132868 ETEX CORPORATION CARRICELL 02/20/2015
K182107 ETEX Corporation CarriGen PF 08/31/2018
K020078 EXACTECH, INC. EXACTECH RESORBABLE BONE PASTE 02/27/2004
K040755 EXACTECH, INC. EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE 06/17/2004
K121989 EXACTECH, INC. OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, 11/27/2012
K130392 GLOBUS MEDICAL INC. KINEX BIOACTIVE 08/15/2013
K102392 GLOBUS MEDICAL INC. MICROFUSE PUTTY AND MICROFUSE ST MIS 12/22/2010
K083232 GLOBUS MEDICAL INC. MODIFICATION TO:MICROFUSE BONE VOID FILLER 12/24/2008
K130977 GLOBUS MEDICAL INC. SIGNIFY BIOACTIVE 12/24/2013
K133678 GLOBUS MEDICAL, INC. CONFIRM BIOACTIVE 08/26/2014
K071187 GLOBUS MEDICAL, INC. MICROFUSE BONE VOID FILLER 12/20/2007
K082442 GLOBUS MEDICAL, INC. MODIFICATION TO MICROFUSE BONE VOID FILLER 10/07/2008
K093343 GRAFTYS GRAFTY QUICKSET 04/22/2010
K073064 GRAFTYS GRAFTYS BCP 03/11/2008
K082498 GRAFTYS GRAFTYS HBS 02/25/2009
K072444 GWOWEI TECHNOLOGY CO., LTD. WELLGRAFT PE I 04/04/2008
K072170 GWOWEI TECHNOLOGY CO., LTD. WELLGRAFT PE II 04/04/2008
K141429 HAIDER BIOLOGICS, LLC SORRENTO BONE GRAFT SUBSTITUTE 02/23/2015
K151271 Hans Biomed Corp. BellaFuse 03/11/2016
K152077 HANS BIOMED CORP. MaxiGen 04/21/2016
K171568 Hans Biomed Corporation SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty 02/22/2018
K033258 HOWMEDICA OSTEONICS BONESAVE BONE VOID FILLER 03/09/2004
K031435 HOWMEDICA OSTEONICS BONESOURCE BVF 08/04/2003
K001559 HOWMEDICA OSTEONICS CORP. CALCIUM SULFATE PELLETS 06/20/2000
K120602 HOYA CORPORATION APACERAM BONE GRAFT SUBSTITUTE 03/23/2012
K070998 INION OY INION BIORESTORE 10/11/2007
K090177 INION OY INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE 02/20/2009
K141841 INTEGRA LIFESCIENCE CORPORTATION INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP 08/01/2014
K063124 INTEGRA LIFESCIENCES CORP. INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS 01/19/2007
K091302 INTEGRA LIFESCIENCES CORPORATION INTEGRA MOZAIK AND OS MOLDABLE MORSELS 12/04/2009
K062353 INTEGRA LIFESCIENCES CORPORATION MOZAIK BONE REGENERATION MATRIX - PUTTY 12/20/2006
K031399 INTERPORE CROSS INTL. INTERGRO DBM 02/18/2005
K991854 INTERPORE CROSS INTL. OSTEOPLAST, MODEL POP200 08/26/1999
K000515 INTERPORE CROSS INTL. PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, 09/15/2000
K004003 INTERPORE CROSS INTL. PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 07/19/2001
K990131 INTERPORE CROSS INTL. PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE 03/02/1999
K980817 INTERPORE INTL. PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L 09/25/1998
K082419 INTRA-LOCK INTERNATIONAL, INC. REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 05/27/2009
K061880 ISOTIS NV ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC 08/15/2007
K030131 ISOTIS NV OSSATURA BCP BONE VOID FILLER 05/20/2003
K050690 ISOTIS ORTHOBIOLOGICS, INC CONNEXUS 07/07/2005
K052098 ISOTIS ORTHOBIOLOGICS, INC CONNEXUS, .5CC, MODEL 023000-005 09/07/2005
K040419 ISOTIS ORTHOBIOLOGICS, INC DYNAGRAFT II 03/25/2005
K070751 ISOTIS ORTHOBIOLOGICS, INC ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY 10/15/2007
K063359 ISTO TECHNOLOGIES, INC. INQU 04/16/2007
K071428 ISTO TECHNOLOGIES, INC. INQU 09/17/2007
K111838 ISTO TECHNOLOGIES, INC. INQU PASTE MIX 09/26/2011
K103799 ISTO TECHNOLOGIES, INC. INQU PASTE MIX PLUS 08/29/2011
K073214 KASIOS DUOWEDGE SYNTHETIC BONE SUBSTITUTE 12/01/2009
K042340 KASIOS BIOMATERIALS KASIOS TCP 11/24/2004
K120141 KENSEY NASH CORORATION KENSEY NASH BONE VOID FILLER XC 05/04/2012
K071237 KENSEY NASH CORP. COPIOS BONE VOID FILLER SPONGE AND PASTE 06/01/2007
K072384 KENSEY NASH CORP. MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE 09/21/2007
K060917 KENSEY NASH CORPORATION KENSEY NASH BONE VOID FILLER 09/22/2006
K173362 Kensey Nash Corporation dba DSM Biomedical DSM Biomedical Calcium Phosphate Cement 04/03/2018
K173572 Kensey Nash Corporation dba DSM Biomedical DSM Biomedical Calcium Phosphate Cement with Microspheres 05/09/2018
K181958 Kuros Biosciences B.V. MagnetOs Putty 12/06/2018
K171563 Kuros Biosciences B.V. MagnetOs Putty 08/24/2017
K082338 KYUNGWON MEDICAL CO., LTD. POLYBONE GRANULE & BLOCK 10/16/2008
K043347 LDR SPINE USA BF+ 01/07/2005
K061462 LDR SPINE USA BF+ (PH) 12/15/2006
K041177 MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG SYNTHACER; SYNTRICER 06/23/2005
K070794 MEDICAL BIOMAT ATLANTIK 07/10/2007
K050490 MEDICREA OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER 04/11/2005
K071813 MEDTRONIC SOFAMOR DANEK MASTERGRAFT PUTTY 11/09/2007
K082918 MEDTRONIC SOFAMOR DANEK MASTERGRAFT RESORBABLE CERAMIC GRANULES 02/09/2009
K082166 MEDTRONIC SOFAMOR DANEK MASTERGRAFT STRIP 06/02/2009
K072265 MEDTRONIC SOFAMOR DANEK PROGENIX DMB PUTTY 01/09/2008
K082002 MEDTRONIC SOFAMOR DANEK PROGENIX PLUS 11/24/2008
K151172 MEDTRONIC SOFAMOR DANEK USA, INC MASTERGRAFT Contain 08/14/2015
K131673 MEDTRONIC SOFAMOR DANEK USA, INC. MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT 10/03/2013
K140375 MEDTRONIC SOFAMOR DANEK USA, INC. MASTERGRAFT PUTTY, MASTERGRAFT STRIP 04/18/2014
K012506 MEDTRONIC SOFAMOR DANEK USA, INC. MASTERGRAFT RESORBABLE CERAMIC GRANULES 03/07/2002
K130335 MEDTRONIC SOFAMOR DANEK USA, INC. MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX 04/19/2013
K123691 MEDTRONIC SOFAMOR DANEK, INC. MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) 01/31/2013
K023553 MEDTRONIC SOFAMOR DANEK, INC. MASTERGRAFT MATRIX 04/22/2003
K141824 MEDTRONIC SOFAMOR DANEK, INC. MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP 09/05/2014
K020986 MEDTRONIC SOFAMOR DANEK, INC. MASTERGRAFT RESORBABLE CERAMIC 07/22/2002
K051386 MEDTRONIC VASCULAR MASTERGRAFT PUTTY BONE VOID FILLER 12/16/2005
K063157 MERRIES INTERNATIONAL INC. MERRIES K-PHATE BONE GRAFT SUBSTITUTE 03/10/2008
K051698 MERRIES INTERNATIONAL INC. MERRIES UNI-OSTEO, MODEL CS30250-CS10102 09/29/2005
K070897 META BIOMED CO., LTD. BONEMEDIK, AND BONEMEDIK-S 09/17/2007
K011726 MILLENIUM BIOLOGIX, INC. MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER 05/16/2002
K170165 Molecular Matrix, Inc. Osteo-P Bone Graft Substitute 12/29/2017
K042125 MUSCULOSKELETAL TRANSPLANT FOUNDATION AFT 07/28/2005
K103784 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY 04/13/2011
K103795 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY 04/13/2011
K091218 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY 09/28/2009
K040262 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX 03/17/2005
K053218 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX 12/28/2006
K121313 MUSCULOSKELETAL TRANSPLANT FOUNDATION MTF NEW BONE VOID FILLER 01/11/2013
K110003 MUSCULOSKELETAL TRANSPLANT FOUNDATION MTF NEW BONE VOID FILLER 10/13/2011
K113167 MUSCULOSKELETAL TRANSPLANT FOUNDATION MTF NEW BONE VOILD FILLER 01/24/2012
K120279 NANOTHERAPEUTICS NANOFUSE DBM 04/06/2012
K062459 NANOTHERAPEUTICS ORIGEN DBM WITH BIOACTIVE GLASS 02/26/2007
K142104 NANOTHERAPEUTICS, INC. NANOFUSE DBM 01/21/2015
K110976 NANOTHERAPEUTICS, INC. ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM 05/03/2011
K000122 NEUCOLL, INC. COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) 09/20/2001
K051406 NEXA ORTHOPEDICS, INC. OSTEOCURE RESORBABLE BEAD KIT 08/01/2005
K112773 NovaBone Products, LLC NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT 10/14/2011
K041613 NovaBone Products, LLC NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE 08/25/2004
K141207 NovaBone Products, LLC NOVABONE BIOACTIVE STRIP 10/31/2014
K163310 NovaBone Products, LLC NovaBone IRM 01/18/2017
K140946 NovaBone Products, LLC NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE 08/22/2014
K152071 NOVABONE PRODUCTS, LLC NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) 08/26/2015
K110925 NovaBone Products, LLC NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT 07/05/2011
K090731 NovaBone Products, LLC NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD 04/15/2009
K060432 NovaBone Products, LLC NOVABONE POROUS-BONE GRAFT SCAFFOLD 04/04/2006
K110368 NovaBone Products, LLC NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT 04/14/2011
K060728 NovaBone Products, LLC NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT 05/01/2006
K051617 NovaBone Products, LLC NOVABONE PUTTY - RESORBABLE BONE VOID FILLER 03/06/2006
K101860 NovaBone Products, LLC NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT 09/01/2010
K080009 NovaBone Products, LLC NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT 05/06/2008
K082672 NovaBone Products, LLC NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT 12/09/2008
K052494 NovaBone Products, LLC NOVABONE-BIOACTIVE SYNTHETIC GRAFT 11/03/2005
K021336 NovaBone Products, LLC NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE 07/25/2002
K172497 NuVasive, Incorporated NuVasive AttraX Scaffold 11/24/2017
K061499 OLYMPUS AMERICA, INC. OSFERION 01/26/2007
K080065 OLYMPUS TERUMO BIOMATERIALS CORPORATION OSFERION 05/02/2008
K140913 ORIENTAL RESOURCES DEVELOPMENT LIMITED NUROS BONE GRAFT SUBSTITUTE 02/17/2015
K012751 ORQUEST, INC. HEALOS BONE GRAFT MATERIAL 11/14/2001
K110787 ORTHOGEM LIMITED TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) 04/21/2011
K070132 ORTHOGEM LIMITED TRIPORE, MODELS HA, BP90, BP15 07/13/2007
K150064 ORTHOGEM LTD Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) 09/04/2015
K142090 ORTHOREBIRTH CO., LTD. REBOSSIS 10/29/2014
K172573 Orthorebirth Co., Ltd. ReBOSSIS85 12/15/2017
K170620 ORTHOREBIRTH Co., Ltd. ReBOSSIS85 06/23/2017
K041616 ORTHOS (UK) LIMITED BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID 08/25/2004
K040514 ORTHOTEC, L.L.C. EOVIA CALCIUM PHOSPHATE CERAMIC 05/03/2004
K994337 ORTHOVITA CO. VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER 12/14/2000
K102545 ORTHOVITA, INC. FM-02 BONE GRAFT SUBSTITUTE 10/27/2010
K161447 ORTHOVITA, INC. HydroSet XT 10/06/2016
K103173 ORTHOVITA, INC. VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE 02/07/2011
K153608 ORTHOVITA, INC. Vitoss BiModal Bone Graft Substitute Foam Strip 02/12/2016
K163621 Orthovita, Inc. Vitoss Bioactive (BA) Injectable 05/02/2017
K072184 ORTHOVITA, INC. VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE 09/18/2007
K081439 ORTHOVITA, INC. VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE 06/17/2008
K083033 ORTHOVITA, INC. VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE 11/06/2008
K032288 ORTHOVITA, INC. VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL 12/19/2003
K032409 ORTHOVITA, INC. VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER 08/29/2003
K032130 ORTHOVITA, INC. VITOSS-FILLED CARTRIDGE 11/05/2003
K051047 OSSACUR AG COLLOSS E BONE VOID FILLER 03/08/2006
K050416 OSSACUR AG OSSAPLAST ORTHO 03/29/2005
K042305 OSSACUR AG OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 10/21/2004
K040047 OSTEOBIOLOGICS, INC. POLYGRAFT BGS; BONE GRAFT SUBSTITUTE 12/17/2004
K030288 OSTEOBIOLOGICS, INC. POLYGRAFT BONE GRAFT SUBSTITUTE 07/17/2003
K033707 OSTEOBIOLOGICS, INC. POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX 08/16/2004
K162087 OsteoNovus, Inc. NovoGro 04/18/2017
K173525 OsteoNovus, Inc. NovoGro 04/06/2018
K082615 OSTEOTECH INC GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES 10/16/2008
K073405 OSTEOTECH, INC. PLEXUR M 03/03/2008
K081227 OSTEOTECH, INC. PLEXUR M 07/22/2008
K080511 OSTEOTECH, INC. PLEXUR-P 04/21/2008
K071912 PENTAX CORP. APACERAM BONE GRAFT SUBSTITUTE 10/29/2007
K083449 PIONEER SURGICAL TECHNOLOGY E-MATRIX GRAFT BONE EXTENDER 06/12/2009
K110561 PIONEER SURGICAL TECHNOLOGY FORTROSS BONE VOID FILLER 04/29/2011
K100361 PIONEER SURGICAL TECHNOLOGY NANOSS BONE VOID FILLER 04/22/2010
K091031 PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL NANOSS BVF-E 11/17/2009
K081558 PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC 08/25/2008
K132050 PIONEER SURGICAL TECHNOLOGY, INC NB3D BONE VOID FILLER 02/07/2014
K111944 PIONEER SURGICAL TECHNOLOGY, INC. NB3D BONE VOID FILLER 11/22/2011
K141600 PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT 10/17/2014
K151584 PROGENTIX ORTHOBIOLOGY B.V. AttraX Putty 10/08/2015
K090641 PROGENTIX ORTHOBIOLOGY B.V. CURIOS 10/23/2009
K060809 PROMED ADVANCE TECHNOLOGY CO., LTD. OSTEO-LINK BONE VOID FILLER PELLETS 07/03/2006
K151154 PROSIDYAN INC. FIBERGRAFT BG Morsels 11/10/2015
K132805 PROSIDYAN, INC BG MORSELS 03/14/2014
K182670 Prosidyan, Inc FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute 12/20/2018
K180080 Prosidyan, Inc FIBERGRAFT BG Matrix Bone Graft Substitute 04/06/2018
K171284 Prosidyan, Inc FIBERGRAFT BG Matrix Bone Graft Substitute 06/30/2017
K141956 PROSIDYAN, INC FIBERGRAFT BG MORSELS 08/13/2014
K170306 Prosidyan, Inc FIBERGRAFT BG Putty Bone Graft Substitute 05/24/2017
K143533 PROSIDYAN, INC. FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE 03/25/2015
K050789 R AND D MEDICAL, LLC FORMAGRAFT COLLAGEN BONE GRAFT MATRIX 05/27/2005
K072238 REGENERATION TECHNOLOGIES, INC. BIOSET XCH 01/25/2008
K072327 REGENERATION TECHNOLOGIES, INC. CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON 10/24/2007
K043421 REGENERATION TECHNOLOGIES, INC. OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC 02/16/2005
K043420 REGENERATION TECHNOLOGIES, INC. OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE 02/10/2005
K051615 REGENERATION TECHNOLOGIES, INC. STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES 08/15/2005
K130953 SBM SCIENCES FOR BIO MATERIALS NEOTIS; NEOTIS 50 07/15/2013
K061022 SCIENCE FOR BIOMATERIALS BIO 1-KIT BIOSORB FILLED CARTRIDGE 05/24/2006
K071155 SCIENCE FOR BIOMATERIALS MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER 07/03/2007
K021963 SCIENCES ET BIO MATERIAUX (SBM) BIOSORB RESORBABLE VOID FILLER 01/28/2003
K040454 SCIENT'X BIOFILL BONE VOID FILLER 05/07/2004
K172130 SeaSpine Orthopedics Corporation Resorbable Mesh Device 11/16/2017
K090387 SIGNUS MEDIZINTECHNIK GMBH KAINOS+ 09/28/2009
K120354 SKELETAL KINETICS, LLC BETA-TCP GRANULES 03/21/2013
K030554 SKELETAL KINETICS, LLC CALLOS 05/20/2003
K100986 SKELETAL KINETICS, LLC CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION 07/20/2010
K051123 SKELETAL KINETICS, LLC CALLOS IMPACT AND INJECT BONE VOID FILLER 06/03/2005
K112383 SKELETAL KINETICS, LLC CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER 02/07/2012
K132211 SKELETAL KINETICS, LLC SKAFFOLD NMX BONE VOID FILLER 08/04/2014
K010555 SMITH & NEPHEW, INC. JAX 02/25/2003
K010557 SMITH & NEPHEW, INC. JAX GRANULES BONE VOID FILLER 05/25/2001
K033552 SMITH & NEPHEW, INC. JAX-TCP 06/10/2004
K062607 SMITH & NEPHEW, INC. POLYGRAFT BGS 11/09/2007
K062496 SPINECRAFT, INC. OSTEOPORE TCP 10/19/2006
K132470 SPINESMITH PARTNERS, LLP SOLUM IV BONE VOID FILLER 05/21/2014
K041421 STRYKER BIOTECH NAME BONE VOID FILLER 08/26/2004
K060061 STRYKER CORP. STRYKER INJECTABLE CEMENT 03/01/2006
K051603 STRYKER LEIBINGER MICRO IMPLANTS STRYKER INJECTABLE CEMENT 12/30/2005
K140844 SYNERGY BIOMEDICAL, INC. BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC 07/16/2014
K122868 Synergy Biomedical, LLC BIOSPHERE BIOACTIVE BONE GRAFT PUTTY 04/19/2013
K173301 Synergy Biomedical, Llc BioSphere MIS Putty (BioSphere MIS) 01/19/2018
K013072 SYNTHES CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) 11/26/2002
K060408 SYNTHES (USA) NORIAN SRS BONE VOID FILLER 03/21/2006
K011897 SYNTHES (USA) NORIAN SRS BONE VOID FILLER 12/20/2001
K060406 SYNTHES (USA) NORIAN SRS FAST SET PUTTY 03/20/2006
K041842 SYNTHES (USA) NORIAN SRS FAST SET PUTTY 07/23/2004
K023862 SYNTHES (USA) NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER 12/19/2002
K043045 SYNTHES (USA) SYNTHES (USA) CHRONOS 01/07/2005
K002362 SYNTHES (USA) SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) 11/01/2000
K071046 SYNTHES (USA) SYNTHES CHRONOS COMPOSITE 10/23/2007
K102722 SYNTHES USA PRODUCTS LLC NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY 01/27/2011
K062691 TAKIRON CO., LTD COMPORUS 04/15/2008
K143692 TCM ASSOCIATES LTD GranOSTM - beta tricalcium phosphate synthetic bone granules 08/21/2015
K041493 TEKNIMED SA CEMENTEK 08/19/2004
K042911 TEKNIMED SA CEMENTEK LV 12/27/2004
K040669 TEKNIMED SA CERAFORM BONE VOID FILLER 05/03/2004
K031826 TEKNIMED SA TRIHA + 11/28/2003
K031040 THERICS, INC. THERIFIL BONE FILLER 07/24/2003
K040134 THERICS, INC. THERILINK BONE VOID FILLER 03/09/2004
K053228 THERICS, LLC THERIGRAFT TCP PUTTY BONE VOID FILLER 01/31/2006
K071876 TRIMED, INC. CROSS.BONE 12/17/2007
K131133 VIVORTE, INC VIVORTE BVF LITE 08/12/2013
K143549 VIVORTE, INC Vivorte Trabexus 01/14/2015
K071199 VIVOXID LTD. BONALIVE GRANULES 02/01/2008
K110949 WILTROM CORPORATION LIMITED BICERA (TM) RESORBABLE BONE SUBSTITUTE 09/18/2012
K172237 Wiltrom Corporation Limited Bicera Resorbable Bone Substitute 02/02/2018
K180758 Wiltrom Corporation Limited Osteocera Resorbable Bone Substitute 10/24/2018
K040980 WRIGHT MEDICAL TECHNOLOGY, INC. ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T 07/14/2004
K053319 WRIGHT MEDICAL TECHNOLOGY, INC. ALLOMATRIX CUSTOM 03/06/2006
K020895 WRIGHT MEDICAL TECHNOLOGY, INC. ALLOMATRIX MODEL# 86 03/05/2004
K041168 WRIGHT MEDICAL TECHNOLOGY, INC. ALLOMATRIX PUTTY 08/02/2004
K041663 WRIGHT MEDICAL TECHNOLOGY, INC. ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM 09/16/2004
K141746 WRIGHT MEDICAL TECHNOLOGY, INC. AS20 COMPOSITE GRAFT 08/04/2014
K031817 WRIGHT MEDICAL TECHNOLOGY, INC. CELLPLEX TCP SYNTHETIC CANCELLOUS BONE 07/17/2003
K052913 WRIGHT MEDICAL TECHNOLOGY, INC. IGNITE BONE VOID FILLER KIT 11/07/2005
K024336 WRIGHT MEDICAL TECHNOLOGY, INC. MIIG II BONE GRAFT SUBSTITUTE 03/04/2003
K060011 WRIGHT MEDICAL TECHNOLOGY, INC. MIIG SR 02/27/2006
K061939 WRIGHT MEDICAL TECHNOLOGY, INC. MODIFICATION TO ALLOMATRIX CUSTOM 07/18/2006
K010532 WRIGHT MEDICAL TECHNOLOGY, INC. OSTEOSET BVF KIT 10/26/2001
K022828 WRIGHT MEDICAL TECHNOLOGY, INC. OSTEOSET DBM PELLETS, MODEL 8600-48XX 04/02/2004
K113871 WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE BONE GRAFT SUBSTITUTE 03/25/2013
K070437 WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE BONE VOID FILLER 05/09/2007
K072597 WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT 10/15/2007
K181255 Wright Medical Technology, Inc. PRODENSE Bone Graft Substitute 09/12/2018
K182823 Wright Medical Technology, Inc. PRODENSE Bone Graft Substitute 11/02/2018
K132656 WRIGHT MEDICAL TECHNOLOGY, INC. PRODENSE BONE GRAFT SUBSTITUTE 03/24/2014
K083270 WRIGHT MEDICAL TECHNOLOGY, INC. WMT COMPOSITE DBM 08/27/2009
K022629 WRIGHT MEDICAL TECHNOLOGY, INC. WMT-TCP BONE GRAFT SUBSTITUTE 11/05/2002
K963587 WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) 03/24/1997
K963562 WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT PLASTER OF PARIS PELLETS 05/07/1997
K960978 WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) 06/21/1996
K161859 XPAND BIOTECHNOLOGY BV MagnetOs 02/24/2017


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact