FDA 510(k) Applications for Medical Device Product Code "JEY"
(Plate, Bone)

FDA 510(k) Number Applicant Device Name Decision Date
K981526 ACE SURGICAL SUPPLY CO., INC. ACE ALVEOLAR DISTRACTOR 11/06/1998
K951392 ACE SURGICAL SUPPLY CO., INC. MINIBONEPLATE SYSTEM 05/05/1995
K990140 ACE SURGICAL SUPPLY CO., INC. NORMED BONE TRANSPORT 03/25/1999
K855030 ADVANCED BIOSEARCH ASSN. CHAMPY BONE PLATES & BONE SCREWS 01/30/1986
K060492 AESCULAP, INC. AESCULAP CRANIOFACIAL PLATE AND SCREW 04/07/2006
K923705 AESCULAP, INC. AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS 02/01/1994
K960514 ANSPACH FIXATION SYSTEMS TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) 04/15/1996
K112457 ARKIN CONSULTING GROUP LEFORTE SYSTEM BONE PLATE & SCREW 05/18/2012
K013672 AZARY TECHNOLOGIES LLC. BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM 04/08/2002
K073307 BIO-TECHNOLOGY USA, INC. MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM 10/29/2008
K110926 BIOMATERIALS KOREA INC. BONE PLATE; BONE SCREW 12/08/2011
K001219 BIOMEDICAL ENT., INC. MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM 06/21/2000
K023488 BIOMEDICAL ENTERPRISES, INC OSSTAPLE, CRANIOFACIAL 10/31/2002
K023486 BIOMEDICAL ENTERPRISES, INC OSSTAPLE, MAXILLOFACIAL 10/31/2002
K953273 BIOMEDICS BIOPLATE RIGID FIXATION BONE PLATING SYSTEM 09/29/1995
K961976 BIOMEDICS THE BIOPLATE FIXATION SYSTEM 08/16/1996
K972463 BIOMEDICS THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 09/25/1997
K980983 BIOMEDICS THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 06/09/1998
K992330 BIOMEDICS THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 11/23/1999
K943071 BIOMEDICS THE TITANIUM FIXATION SYSTEM 01/06/1995
K121589 BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM 09/21/2012
K113512 BIOMET MICROFIXATION BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM 06/29/2012
K143336 BIOMET MICROFIXATION Biomet Microfixation OmniMax MMF System 04/01/2015
K152326 BIOMET MICROFIXATION Biomet Microfixation OmniMax MMF System 12/10/2015
K132600 BIOMET MICROFIXATION FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING 10/02/2013
K131674 BIOMET MICROFIXATION PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING 08/08/2013
K081067 BIOMET MICROFIXATION, INC. FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) 05/09/2008
K981070 BIOMET, INC. 20-HOLE ADAPTATION PLATE 05/20/1998
K980927 BIOMET, INC. LACTOSORB PANELS AND FASTENERS 06/05/1998
K003281 BIOMET, INC. LACTOSORB RAPIDFLAP 08/07/2001
K992158 BIOMET, INC. LACTOSORB SHEETS 08/20/1999
K982139 BIONX IMPLANTS, INC. BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM 09/15/1998
K982721 BIONX IMPLANTS, INC. BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM 02/17/1999
K010687 BIONX IMPLANTS, INC. BIOSORBFX AND BIOSORBPDX MESH 03/14/2001
K011569 BIONX IMPLANTS, INC. BIOSORBFX O/M 2.0/2/4 SYSTEM 02/22/2002
K003756 BIONX IMPLANTS, INC. BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES 01/03/2001
K000836 BIONX IMPLANTS, INC. BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM 06/08/2000
K003757 BIONX IMPLANTS, LTD. THERMOFX MESH 02/07/2001
K030806 BIOPLATE, INC. BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 04/08/2003
K002879 BIOPLATE, INC. MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM 10/05/2000
K023665 BIOPLATE, INC. MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 11/22/2002
K023810 BIOPLATE, INC. MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 12/04/2002
K011380 BIOPLATE, INC. MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM 05/14/2001
K022890 BIOPLATE, INC. MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 09/06/2002
K082757 BIOPLATE, INC. MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM 10/01/2008
K022033 BIOPLATE, INC. STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM 07/19/2002
K001530 BIOPLATE, INC. THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM 07/21/2000
K013055 BIOPLATE, INC. THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM 12/07/2001
K012910 BIOPLATE, INC. THE BIOPLATE MANDIBLE FIXATION SYSTEM 11/20/2001
K002426 BIOPLATE, INC. THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY 01/26/2001
K994060 BIOPLATE, INC. THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE 01/24/2001
K051845 BIOPLATE, INC. THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM 07/27/2005
K031028 BIOPLATE, INC. THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 04/28/2003
K021684 BIOPLATE, INC. THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY 06/26/2002
K040650 BIOTECH ONE, INC. BONAMATES SERIES 06/03/2004
K855224 BUCKMAN CO., INC. ACROMED NESTED BONE PLATE 02/04/1986
K913688 BUD INDUSTRIES, INC. BUD MAXILLOFACIAL IMPLANT SYSTEM 05/05/1992
K884523 BUSCHMANN SURGICAL PRODUCTS MARTIN-CHAMPY "TITAN" SET 12/08/1988
K051293 CEREMED, INC. CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM 06/14/2005
K992905 Codman & Shurtleff, Inc. CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM 08/01/2000
K002798 Codman & Shurtleff, Inc. CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS 12/06/2000
K003549 Codman & Shurtleff, Inc. CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS 02/15/2001
K990920 DOCTOR'S RESEARCH GROUP, INC. DRG TITANIUM BONE PLATE 06/10/1999
K973924 FRIATEC AG FRIOS BONESHIELD 05/07/1998
K091812 FRONTIER DEVICES, INC. FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS 05/07/2010
K901095 GRIMM & NORTON BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY 04/27/1990
K901094 GRIMM & NORTON HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY 04/27/1990
K983535 HANS HERMANN GMBH THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 12/29/1998
K901941 HOWMEDICA CORP. LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES 09/06/1990
K950595 HOWMEDICA CORP. LUHR MANDIBULAR/SMALL FIXATION IMPLANTS 07/12/1995
K901940 HOWMEDICA CORP. LUHR MICRO MESH 09/06/1990
K983528 HOWMEDICA CORP. MICRO DYNAMIC MESH 12/23/1998
K972154 HOWMEDICA LEIBINGER, INC. COHEN DISTRACTOR 08/11/1997
K972166 HOWMEDICA LEIBINGER, INC. GUERRERO - BELL DISTRACTOR 08/11/1997
K970911 HOWMEDICA LEIBINGER, INC. LEE PLATE 04/11/1997
K963740 HOWMEDICA LEIBINGER, INC. LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS 10/28/1996
K964649 HOWMEDICA LEIBINGER, INC. VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE 01/24/1997
K983885 HOWMEDICA, INC. BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES 01/29/1999
K973484 HOWMEDICA, INC. CHIN DISTRACTOR 12/02/1997
K141764 IMPLADENT, LTD. TRISTAR BONE GRAFT FIXATION SYSTEM 12/18/2014
K952812 IMPLANT INNOVATIONS, INC. 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS 08/30/1995
K952811 IMPLANT INNOVATIONS, INC. 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS 08/30/1995
K960914 IMPLANT INNOVATIONS, INC. 3I OSSEOUS FIXATION SYSTEM(S) 04/04/1996
K953386 IMPLANT INNOVATIONS, INC. 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS 09/15/1995
K970841 IMTEC CORP. IMTEC/TITANIUM MESH 04/30/1997
K862139 IMTECH, INC. IMTECH FIXATION SYSTEMS 07/16/1986
K010352 INION LTD. CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM 03/14/2001
K013039 INION LTD. INION CPS 2.0 ORTHOGNATHIC PLATE 10/05/2001
K010351 INION LTD. INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM 03/15/2001
K052444 INION LTD. INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM 09/20/2005
K051341 INION LTD. INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 05/27/2005
K033194 INION LTD. INION CPS BABY 1.5 BIOABSORBABLE SYSTEM 10/30/2003
K122890 INION OY INION CPS ORBITAL PLATES 01/29/2013
K011698 INSTITUT STRAUMANN AG STRAUMANN GBR SYSTEM 08/23/2001
K143730 JEIL MEDICAL CORPORATION GBR System 06/10/2015
K050669 JEIL MEDICAL CORPORATION JEIL BONE FIXATION SYSTEM 05/26/2005
K103778 JEIL MEDICAL CORPORATION LEFORTE NEURO SYSTEM BONE PLATE 01/26/2011
K091679 JEIL MEDICAL CORPORATION LEFORTE SYSTEM BONE PLATE 10/02/2009
K150965 Jeil Medical Corporation LeForte System II 09/17/2015
K950045 KARL LEIBINGER GMBH U. CO. KG KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM 03/23/1995
K060177 KLS MARTIN L.P. KLS MARTIN RIGID FIXATION - STERILE 04/18/2006
K163579 KLS Martin LP KLS Martin Individual Patient Solutions 11/21/2017
K173320 KLS Martin LP KLS Martin L1 MMF System 02/23/2018
K180962 KLS-Martin L.P. KLS Martin Individual Patient Solutions 08/13/2018
K944565 KLS-MARTIN L.P. KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) 10/18/1994
K944560 KLS-MARTIN L.P. MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST 10/18/1994
K944561 KLS-MARTIN L.P. MICRO OSTEOSYNTHESIS SYSTEM (1.0) 10/18/1994
K994154 KLS-MARTIN L.P. MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES 02/15/2000
K003883 KLS-MARTIN L.P. MOLINA ORBITAL MALAR DISTRACTOR 01/23/2001
K112064 KLS-MARTIN L.P. RESORB X-G 03/23/2012
K011590 KLS-MARTIN L.P. RESORB-X RESORBABLE PLATING SYSTEM 03/20/2002
K051236 KLS-MARTIN L.P. RESORB-X SF 08/22/2005
K133304 KLS-MARTIN L.P. RXG DISTRACTION SYSTEM 05/15/2014
K080862 KLS-MARTIN L.P. SONICWELD RX (RESORB-X) 07/21/2008
K061507 KLS-MARTIN L.P. SONICWELD RX ENDOBROW FIXATION 09/21/2006
K042517 LINVATEC BIOMATERIALS, LTD. BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS 10/08/2004
K012413 MACROPORE BIOSURGERY, INC. MACROPORE FX, PS, NS, LP 09/18/2001
K000696 MACROPORE BIOSURGERY, INC. MACROPOREMX MANDIBULAR FIXATION SYSTEM 10/19/2000
K002207 MACROPORE BIOSURGERY, INC. MACROPOREPX PEDIATRIC SYSTEM 07/11/2001
K103136 MATERIALISE N.V. SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE 03/18/2011
K173039 Materialise NV TruMatch CMF Titanium 3D Printed Implant 07/10/2018
K170272 Materialise NV TruMatch CMF Titanium 3D Printed Implant System 08/08/2017
K992682 MEDARTIS AG MODUS 2.5 MANDIBULAR RECONSTRUCTION SET 11/24/1999
K992683 MEDARTIS AG MODUS 2.5 MANDIBULAR TRAUMA SET 11/24/1999
K071612 MEDARTIS AG MODUS TRILOCK 2.0/2.3/2.5 09/11/2007
K050934 MEDARTIS, INC. MODUS TITANIUM OSTEOSYNTHESIS SYSTEM 05/05/2005
K951691 MEDICON, E.G. CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM 07/26/1995
K970256 MEDICON, E.G. INTRAORAL MANDIBULAR DISTRACTION DEVICE 03/11/1997
K043297 MEDICON, E.G. MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM 02/23/2005
K951687 MEDICON, E.G. MESH TITANIUM IMPLANT SYSTEM 07/27/1995
K951688 MEDICON, E.G. MICRO TITANIUM PLATE SYSTEM 07/26/1995
K951689 MEDICON, E.G. TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM 07/27/1995
K951690 MEDICON, E.G. TITANIUM MINIPLATE SYSTEM 07/26/1995
K952168 MEDICON, INC. TITANIUM MANDIBULAR FRACTURE SYSTEM 06/22/1995
K110259 MEDTRONIC SOFAMOR DANEK USA, INC. ARCHITEX SPACE MAINTENANCE SYSTEM 04/13/2011
K120271 MEDTRONIC SOFAMOR DANEK USA, INC. ARTISAN SPACE MAINTENANCE SYSTEM 05/30/2012
K100779 MEDTRONIC SOFAMOR DANEK USA, INC. SUSTAIN SPACE MAINTENANCE SYSTEM 12/13/2010
K131289 MEGAGEN IMPLANT CO., LTD I-GEN 09/25/2013
K932492 MICRO SURGICAL INSTRUMENTS CORP. IMPLANTOLOGY MODULE, MODEL 2175 10/05/1993
K062436 MONDEAL MEDICAL SYSTEMS GMBH SIS SINUS IMPLANT STABILIZER 07/30/2007
K111761 NEOBIOTECH CO., LTD. NEO TITANIUM MESH, CTI-MEM 01/10/2012
K102641 NEOORTHO PRODUTOS ORTOPEDICOS S/A MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE 12/20/2010
K931539 NORMED MEDIZIN-TECHNIK GMBH NORMED TITANIUM MINIPLATE SYSTEM 07/05/1994
K030989 NOVIACE CORPORATION OSTEOSORB TACK FIXATION SYSTEM 04/01/2004
K896404 OPTIK TITAMED ANTWERP SYSTEM 04/16/1990
K033092 ORTHO GNATHICS LLC THE GNATHOMETER 04/21/2004
K172354 Osstem Implant Co., Ltd.. OssBuilder System 03/26/2018
K120951 OSSTEM IMPLANT CO.,LTD SMARTBUILDER SYSTEM 10/03/2012
K130840 OSSTEM IMPLANT CO.,LTD SMARTBUILDER SYSTEM (SB1) 09/18/2013
K984230 OSTEOGENICS BIOMEDICAL, INC. OSTEO-MESH TM-300 02/04/1999
K140978 OSTEOMED OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM 12/18/2014
K021618 OSTEOMED CORP. OSA RIGID INTERNAL FIXATION SYSTEM 08/08/2002
K924138 OSTEOMED CORP. OSTEOMED M3 SYSTEM (SBF SYSTEM) 02/17/1993
K963394 OSTEOMED CORP. OSTEOMED TRAM 11/14/1996
K143338 OSTEOMED L.P. Argulated Locking Plates 04/01/2015
K030448 OSTEOMED L.P. OSTEOMED 2.0 LOCKING PLATES AND SCREWS 05/09/2003
K080694 OSTEOMED L.P. OSTEOMED MODULAR LOCKING FIXATION SYSTEM 05/15/2008
K021342 OSTEOMEDICS, INC. NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR 08/01/2002
K021341 OSTEOMEDICS, INC. NORMED BONE TRANSPORT DISTRACTION DEVICE 08/01/2002
K010118 OSTEOMEDICS, INC. NORMED MANDIBULAR FIXATION SYSTEM 08/14/2001
K022035 OSTEOMEDICS, INC. OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB 01/17/2003
K160363 OSTEONIC Co., Ltd. OPTIMUS CMF SYSTEM 10/20/2016
K140037 OSTEONIC CO., LTD. OPTIMUS CMF SYSTEM 01/20/2015
K983360 PACIFIC MATERIALS AND INTERFACES MACROPORE PROTECTIVE SHEET 03/19/1999
K943348 PATTON, BOGGS & BLOW KLS CHIN PLATE SYSTEM 10/04/1994
K943347 PATTON, BOGGS & BLOW KLS MINI OSTEOSYNTHESIS SYSTEM 10/04/1994
K943345 PATTON, BOGGS & BLOW MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM 10/04/1994
K943346 PATTON, BOGGS & BLOW MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM 10/04/1994
K091807 POREX SURGICAL, INC. MEDPOR FIXATION SYSTEM 06/28/2010
K072528 PROSURG, INC. ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES 12/28/2007
K070737 PROSURG, INC. XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES 07/25/2007
K072463 SATYRNE MEDICAL SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM 11/29/2007
K973145 SOFAMOR DANEK USA,INC. TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM 11/19/1997
K873926 STORZ INSTRUMENT CO. STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT 02/19/1988
K121235 Stryker LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM 01/09/2014
K171364 Stryker MP LeFort I Plates 07/24/2017
K132519 Stryker STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT 12/06/2013
K142568 Stryker Stryker MEDPOR TITAN 3D Orbital Floor Implant 05/05/2015
K170773 Stryker Stryker Universal Mesh 11/08/2017
K133461 Stryker STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM 08/01/2014
K123786 Stryker STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM 04/09/2013
K122313 Stryker STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM 10/31/2012
K172572 Stryker Stryker Upper-Face AXS screws and Mid-Face AXS screws 10/31/2017
K092743 STRYKER CRANIOMAXILLOFACIAL THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM 01/15/2010
K003660 STRYKER INSTRUMENTS LEIBINGER NEURO CLIP SYSTEM 12/12/2000
K002619 STRYKER INSTRUMENTS NEWGEN SYSTEM 11/16/2000
K014263 STRYKER INSTRUMENTS NEWGEN/UNIVERSAL MANDIBULAR SYSTEM 03/08/2002
K022185 STRYKER INSTRUMENTS UNIVERSAL CMF SYSTEM 12/17/2002
K031659 STRYKER INSTRUMENTS UNIVERSAL NEURO SYSTEM 09/10/2003
K000594 STRYKER LEIBINGER LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE 12/08/2000
K170697 SURGIDENT GBR system 05/24/2018
K033121 SYNTHES (USA) 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES 10/20/2003
K840955 SYNTHES (USA) CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD 06/19/1984
K003393 SYNTHES (USA) MAXILLARY DISTRACTOR 01/17/2001
K042987 SYNTHES (USA) MODIFICATION TO SYNTHES CRANIAL PLATES 11/23/2004
K003786 SYNTHES (USA) SMF RESORBABLE MESHES AND SHEETS 02/27/2001
K021382 SYNTHES (USA) SYNTHES (USA) AUTOMATED TACK DRIVER 05/16/2002
K040272 SYNTHES (USA) SYNTHES (USA) CRANIOFACIAL PLATES 02/23/2004
K010499 SYNTHES (USA) SYNTHES (USA) MIDFACE DISTRACTOR 05/03/2001
K953806 SYNTHES (USA) SYNTHES (USA) MIDFACIAL SYSTEM 03/08/1996
K042365 SYNTHES (USA) SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM 11/18/2004
K031761 SYNTHES (USA) SYNTHES (USA) NEW/STERIAL ORBITAL PLATES 09/03/2003
K062789 SYNTHES (USA) SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM 02/27/2007
K021928 SYNTHES (USA) SYNTHES (USA) RESORBABLE FIXATION SYSTEM 09/06/2002
K000560 SYNTHES (USA) SYNTHES (USA) RESORBABLE TACK SYSTEM 01/09/2001
K964328 SYNTHES (USA) SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE 12/13/1996
K971987 SYNTHES (USA) SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR 06/24/1997
K981890 SYNTHES (USA) SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES 08/18/1998
K974555 SYNTHES (USA) SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) 03/03/1998
K961421 SYNTHES (USA) SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM 06/26/1996
K050608 SYNTHES (USA) SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM 05/18/2005
K020087 SYNTHES (USA) SYNTHES CRANIAL PLATES 02/20/2002
K080331 SYNTHES (USA) SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM 04/30/2008
K021642 SYNTHES (USA) SYNTHES CRANIOFACIAL PLATES 08/14/2002
K102656 SYNTHES (USA) SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM 12/20/2010
K022012 SYNTHES (USA) SYNTHES LOW PROFILE NEURO SYSTEM 11/01/2002
K954385 SYNTHES (USA) SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM 03/08/1996
K082335 SYNTHES (USA) SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM 11/10/2008
K091144 SYNTHES (USA) SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES 08/25/2009
K091233 SYNTHES (USA) SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES 12/11/2009
K083388 SYNTHES (USA) SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM 03/12/2009
K022005 SYNTHES (USA) SYNTHES MIDFACE DISTRACTOR 09/03/2002
K030069 SYNTHES (USA) SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM 04/08/2003
K050204 SYNTHES (USA) SYNTHES RAPID RESORBABLE TACK SYSTEM 03/04/2005
K022844 SYNTHES (USA) SYNTHES RESORBABLE CONTOURABLE MESH 01/07/2003
K974554 SYNTHES (USA) SYNTHES RESORBABLE FIXATION SYSTEM 02/24/1998
K033160 SYNTHES (USA) SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES 10/09/2003
K020505 SYNTHES (USA) SYNTHES TRANSLATING MAXILLARY DISTRACTOR 04/23/2002
K063790 SYNTHES (USA) THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM 04/16/2007
K141165 SYNTHES (USA) PRODUCTS LLC MATRIXWAVE MMF SYSTEM 10/17/2014
K113567 SYNTHES INC SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM 11/19/2012
K121574 SYNTHES INC SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM 06/29/2012
K113251 SYNTHES INC SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES 12/21/2011
K122647 SYNTHES INC SYNTHES PATIENT SPECIFIC PLATE 02/28/2013
K061881 TAKIRON CO., LTD OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM 03/14/2007
K921801 TECHMEDICA, INC. MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM 07/15/1992
K031989 TEKKA ORTRAUTEK ORTHOGNATHIC SYSTEM 10/28/2003
K032520 TEKKA ORTRAUTEK TRAUMA SYSTEM 11/12/2003
K870041 THE DECA CO. FLEXIBLE FASCICULATED BONE PLATE 07/17/1987
K993862 THE STRAUMANN CO. MODUS SAGITTAL SPLIT PLATE 12/29/1999
K923802 TI-MESH, INC. TIMESH TITANIUM MINI-SOFTPLATE/SCREW 10/26/1992
K923419 TI-MESH, INC. TISMESH SYSTEM 04/08/1993
K021511 UNICARE BIOMEDICAL, INC. CYTOFLEX MESH 08/06/2002
K862532 WALTER LORENZ SURGICAL, INC. DUMBACH TITANIUM MESH IMPLANT SYSTEM 09/05/1986
K922741 WALTER LORENZ SURGICAL, INC. LORENZ 1.0 MM SYSTEM 12/23/1992
K953385 WALTER LORENZ SURGICAL, INC. LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM 09/28/1995
K972322 WALTER LORENZ SURGICAL, INC. LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES 08/18/1997
K980512 WALTER LORENZ SURGICAL, INC. LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW 05/11/1998
K030425 WALTER LORENZ SURGICAL, INC. LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER 05/14/2004
K002083 WALTER LORENZ SURGICAL, INC. LORENZ RESORBABLE DISTRACTOR SYSTEM 02/12/2001
K063052 WALTER LORENZ SURGICAL, INC. LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES 01/12/2007
K001238 WALTER LORENZ SURGICAL, INC. LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM 05/03/2000
K910038 WALTER LORENZ SURGICAL, INC. LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM 02/20/1991
K862505 WALTER LORENZ SURGICAL, INC. MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM 08/07/1986
K862533 WALTER LORENZ SURGICAL, INC. MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE 08/01/1986
K862534 WALTER LORENZ SURGICAL, INC. PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS 08/07/1986
K862482 WALTER LORENZ SURGICAL, INC. STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS 07/25/1986
K854886 WALTER LORENZ SURGICAL, INC. WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS 01/21/1986
K945500 WELLS JOHNSON CO. WELLS JOHNSON FIXATION SYSTEM 09/21/1995


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