FDA 510(k) Applications for Medical Device Product Code "KTT"
(Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)

FDA 510(k) Number Applicant Device Name Decision Date
K071852 AAP IMPLANTATE AG AAP APS SYSTEM 08/29/2007
K813554 ACE ORTHOPEDIC MANUFACTURING CO. ACE/KYLE CAPTURED HIP SCREW 01/12/1982
K101170 ACUTE INNOVATIONS LLC ACUTE INNOVATIONS STERNAL FIXATION SYSTEM 09/17/2010
K905514 ADVANCED BIOSEARCH ASSN. AUTOGENESIS(TM) AUTOMATOR 04/02/1991
K141912 ADVANCED ORTHOPAEDIC SOLUTIONS, INC. AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON 10/29/2014
K080408 ADVANCED ORTHOPAEDIC SOLUTIONS, INC. EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD 04/25/2008
K102057 AESCULAP IMPLANT SYSTEMS, LLC TARGON FN SYSTEM 12/21/2010
K051554 ALLIANCE MEDICAL CORP. ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES 06/29/2005
K052062 ALLIANCE MEDICAL CORP. ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES 08/25/2005
K052064 ALLIANCE MEDICAL CORP. ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES 08/25/2005
K052065 ALLIANCE MEDICAL CORP. ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES 08/22/2005
K032058 ALLIANCE MEDICAL CORP. MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES 07/30/2003
K012623 ALLIANCE MEDICAL CORP. REPROCESSED EXTERNAL FIXATION DEVICE 06/24/2002
K023714 ALLIANCE MEDICAL CORP. REPROCESSED EXTERNAL FIXATION DEVICE 02/03/2003
K052918 ALLIANCE MEDICAL CORP. REPROCESSED EXTERNAL FIXATION DEVICES 01/27/2006
K012648 ALLIANCE MEDICAL CORP. REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES 06/24/2002
K926417 ALPHATEC MFG., INC. ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW 09/28/1994
K964400 ALPHATEC MFG., INC. ALPHATEC EXTERNAL FIXATION SYSTEM 04/28/1997
K993873 ALPHATEC MFG., INC. ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD 01/03/2000
K923032 AMP, INC. FIXEL EXTERNAL FIXATION DEVICE 10/04/1993
K091619 ANGLEFIX ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) 09/08/2009
K162032 Arrowhead DE, LLC Arrowhead Mini-Rail Fixator 02/21/2017
K140463 ASCENSION ORTHOPEDIC INTEGRA EXTERNAL FIXATION SYSTEM 10/10/2014
K160830 Ascension Orthopedics Integra External Fixation System 07/06/2016
K061759 ASCENT HEALTHCARE SOLUTIONS REPROCESSED EXTERNAL FIXATION DEVICE 09/05/2006
K071395 BIOMET MANUFACTURING CORP. BIOMET VISION FOOTRING SYSTEM 07/09/2007
K081244 BIOMET TRAUMA LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS 07/30/2008
K102843 BIOMET TRAUMA (AKA EBI LLC) MAC MALE ADAPTER 05/03/2011
K980370 BIOMET, INC. BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR 04/14/1998
K110426 BK MEDITECH CO., LTD. DYNA-EXTOR II 11/02/2011
K842768 BUCKMAN CO., INC. ACE/FISHER EXTERNAL FIXATOR 09/21/1984
K150579 CARDINAL HEALTH Cardinal Health External Fixation System 04/29/2015
K113384 CITIEFFE EXTERNAL FIXATOR ST.A R 90 F4 05/01/2012
K163323 CITIEFFE s.r.l Dolphix« External Fixation System MR Conditional 03/20/2017
K132363 CITIEFFE S.R.L. DOLPHIX EXTERNAL FIXATION SYSTEM 01/16/2014
K973231 CORIN U.S.A. THE CORIFIX DYNAMIC HIP SCREW SYSTEM 11/20/1997
K113106 D.N.E., LLC DNE EXTERNAL FIXATION SYSTEM 01/04/2012
K140158 D.N.E., LLC S.E.A.L. FRACTURE FUSION TUBE 05/29/2014
K890814 DANEK MEDICAL, INC. DANEK RING FIXATOR (DRF) 06/13/1989
K891066 DANEK MEDICAL, INC. DANEK WRIST FIXATOR 08/28/1989
K052498 DAVID J. SLUTSKY MD FRAGMENT SPECIFIC FIXATOR 10/17/2005
K083789 DEPUY ORTHOPAEDICS, INC. ACE FISCHER EXTERNAL FIXATION SYSTEM 03/23/2009
K112218 DEPUY ORTHOPAEDICS, INC. ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS 12/15/2011
K003397 DEPUY ORTHOPAEDICS, INC. COLLES C SERIES FRAME STERILE PACK 01/29/2001
K063509 DEPUY ORTHOPAEDICS, INC. DEPUY PEAK FX HIP PLATE 01/04/2007
K013503 DEPUY ORTHOPAEDICS, INC. MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR 11/16/2001
K021933 DEPUY ORTHOPAEDICS, INC. TEMPFIX EXTERNAL FIXATION SYSTEM 08/26/2002
K043113 DEPUY ORTHOPAEDICS, INC. TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE 01/21/2005
K172872 DePuy Synthes DePuy Synthes Femoral Neck System 03/05/2018
K972629 DEPUY, INC. DEPUY AE TK2 HIP SCREW SYSTEM 10/09/1997
K946156 DEPUY, INC. DEPUY COMPRESSION HIP SCREW SYSTEM 05/03/1995
K861178 DEPUY, INC. DEPUY COMPRESSION HIP SCREW SYSTEM 04/15/1986
K140822 DEVISE ORTHO, INC. DRIVE RAIL SYSTEM 05/29/2014
K031401 DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) 08/06/2003
K151580 DNE, LLC D.N.E. External Fixation System 02/16/2016
K811017 DOWNS SURGICAL LTD. HUCKSTEP INTRAMEDULLARY NAIL 05/27/1981
K904973 DYNASPLINT SYSTEMS, INC. EXTERNAL FIXATION 02/21/1991
K093057 EBI, L.P. BIOMET VISION FOOTRING SYSTEM 12/01/2009
K021312 EBI, L.P. EBI DFS OPTIROM ELBOW FIXATOR 05/23/2002
K021695 EBI, L.P. EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM 06/20/2002
K052239 EBI, L.P. EBI DYNAFIX VISION FOOTPLATE SYSTEM 09/21/2005
K970290 EBI, L.P. EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM 04/01/1997
K013540 EBI, L.P. EBI XFIX ACCESS PELVIC FIXATOR 11/20/2001
K011697 EBI, L.P. EBI XFIX ACCESS PELVIC FIXATOR 06/27/2001
K001358 EBI, L.P. EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM 05/23/2000
K992515 EBI, L.P. EBI XFIX DFS OPTIROM ELBOW FIXATOR 08/17/1999
K000083 EBI, L.P. EBI XFIX DFS RAIL SYSTEM 02/03/2000
K031919 EBI, L.P. EBI XFIX DFS SYSTEM 09/04/2003
K013378 EBI, L.P. EBI XFIX DFS SYSTEM 11/08/2001
K040935 EBI, L.P. EBI XFIX DFS SYSTEM 07/06/2004
K021091 EBI, L.P. EBI XFIX DFS SYSTEM 05/03/2002
K000319 EBI, L.P. EBI XFIX DFS SYSTEM 02/25/2000
K022319 EBI, L.P. EBI XFIX DFS SYSTEM 08/12/2002
K023399 EBI, L.P. EBI XFIX DFS SYSTEM 10/25/2002
K031645 EBI, L.P. EBI XFIX DFS SYSTEM 06/25/2003
K012024 EBI, L.P. EBI XFIX DFS SYSTEM 07/25/2001
K993649 EBI, L.P. EBI XFIX DFS WRISTFIX SYSTEM 11/19/1999
K031093 EBI, L.P. EBI XFIX OPTIROM KNEE FIXATOR 07/10/2003
K021031 EBI, L.P. EBI XFIX RAIL SYSTEM 05/16/2002
K993886 EBI, L.P. EBI XFIX VISION FIXATION SYSTEM 12/14/1999
K030372 EBI, L.P. MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM 03/06/2003
K011711 EBI, L.P. MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM 06/29/2001
K020403 EBI, L.P. MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR 03/08/2002
K010437 EBI, L.P. MODIFICATION TO EBI XFIX DFS RAIL SYSTEM 03/13/2001
K014276 EBI, L.P. MODIFICATION TO EBI XFIX DFS SYSTEM 03/01/2002
K023324 EBI, L.P. MODIFICATION TO EBI XFIX DFS SYSTEM 10/18/2002
K024129 EBI, L.P. MODIFICATION TO EBI XFIX DFS SYSTEM 01/15/2003
K024248 EBI, L.P. MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM 01/22/2003
K033635 EBI, L.P. MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM 12/03/2003
K014194 EBI, L.P. MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM 01/17/2002
K020141 EBI, L.P. MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM 02/05/2002
K040833 EBI, L.P. MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM 04/29/2004
K111376 EBI, LLC CONSTRUX EXTERNAL FIXATION DEVICE 08/03/2011
K981483 ELECTRO-BIOLOGY, INC. EBI DFS JOINT FIXATOR, MODEL 02800 07/08/1998
K951357 ELECTRO-BIOLOGY, INC. EBI SMALL EXTERNAL FIXATOR (S/E/F/) 06/21/1995
K953406 ELECTRO-BIOLOGY, INC. EBI X FIX DYNAFIX SYSTEM (DFS) 10/31/1995
K961433 ELECTRO-BIOLOGY, INC. EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS 06/28/1996
K991941 ELECTRO-BIOLOGY, INC. EBI XFIX DFS RAIL SYSTEM 08/19/1999
K140675 EMERGE MEDICAL, INC. EMERGE EXTERNAL FIXATION SYSTEM 06/10/2014
K951809 ENCORE ORTHOPEDICS, INC. GLIDING NAIL 07/13/1995
K111155 EXTRAORTHO INC XTRAFIX EXTERNAL FIXATION SYSTEM 10/20/2011
K113383 EXTRAORTHO, INC. XTRAFIX EXTERNAL FIXATION SYSTEM 06/26/2012
K964094 FERGUSON MEDICAL MINIFIX 11/27/1996
K023314 FIXANO SA MICROFIX 10/18/2002
K012062 FIXANO SA PF2 09/27/2001
K012078 FIXANO SA RADIOFIX 09/27/2001
K022771 FIXANO SA TWIN FIX 09/23/2002
K160972 Gexfix International Corp. Gexfix External Fixation 12/28/2016
K052605 GEXFIX USA INC. EXTERNAL FIXATION 11/10/2005
K172438 Globus Medical Inc. ARBOR External Fixation System 01/12/2018
K033112 HAND BIOMECHANICS LAB, INC. WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS 11/05/2003
K041081 HAND INNOVATIONS, INC. FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES 07/01/2004
K061748 HAND INNOVATIONS, LLC. FRAGMENT PLATE SYSTEM 07/17/2006
K163486 HNM Total Recon, LLC DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates 07/24/2017
K925127 HOWMEDICA CORP. ALTA CANCELLOUS BONE SCREW 03/22/1993
K961213 HOWMEDICA CORP. ALTA DOME AND PLUNGER (MEC HIP BOLT) 06/13/1996
K900584 HOWMEDICA CORP. ALTA LAG SCREW AND COMPRESSION SCREW 04/18/1990
K873459 HOWMEDICA CORP. ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT 10/28/1987
K915599 HOWMEDICA CORP. CAP WASHER ASSEMBLY 10/01/1993
K823548 HOWMEDICA CORP. COMPRESSION HIP SCREW SIDE-PLATE 12/28/1982
K893639 HOWMEDICA CORP. GAMMA LOCKING NAIL 08/03/1989
K944883 HOWMEDICA CORP. GAMMA LOCKING NAIL - LONG LENGTH 11/28/1994
K932174 HOWMEDICA CORP. GAMMA LOCKING NAIL-CROSS LOCKING SCREWS 03/07/1994
K910986 HOWMEDICA CORP. HOFFMANN DYNAMIC WRIST FIXATOR 01/16/1992
K930836 HOWMEDICA CORP. HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM 01/18/1995
K872223 HOWMEDICA CORP. MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM 06/26/1987
K872224 HOWMEDICA CORP. MODIFIED TROCHANTER CABLE GRIP SYSTEM 08/17/1987
K910483 HOWMEDICA CORP. MONOTUBE EXTERNAL FIXATION SYSTEM 07/14/1992
K910993 HOWMEDICA CORP. MORREY ELBOW FIXATOR 11/25/1992
K922295 HOWMEDICA CORP. OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION 09/08/1992
K955306 HOWMEDICA CORP. OMEGA+ COMPRESSION SCREW SYSTEM 04/10/1996
K790501 HOWMEDICA CORP. PEDIATRIC OSTEOTOMY SYSTEM 04/10/1979
K945233 HOWMEDICA CORP. PEDIATRIC OSTEOTOMY SYSTEM 02/01/1995
K844068 HOWMEDICA CORP. TROCHANTER CABLE GRIP SYSTEM 06/21/1985
K050048 HOWMEDICA OSTEONICS CORP HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM 03/04/2005
K053038 HOWMEDICA OSTEONICS CORP HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM 11/22/2005
K053472 HOWMEDICA OSTEONICS CORP HOFFMANN II MRI EXTERNAL FIXATION SYSTEM 01/11/2006
K053349 HOWMEDICA OSTEONICS CORP HOFFMANN II ROD TO WIRE COUPLING 12/09/2005
K052037 HOWMEDICA OSTEONICS CORP MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 08/05/2005
K070454 HOWMEDICA OSTEONICS CORP OMEGA 3 SUPRACONDYLAR PLATE 04/12/2007
K062066 HOWMEDICA OSTEONICS CORP OMEGA 3 SYSTEM 08/15/2006
K073527 HOWMEDICA OSTEONICS CORP VARIAX ELBOW SYSTEM 02/14/2008
K092834 HOWMEDICA OSTEONICS CORP. HOFFMAN XPRESS LINE EXTENSION 10/08/2009
K041706 HOWMEDICA OSTEONICS CORP. HOFFMANN II FOOT RING 09/08/2004
K042019 HOWMEDICA OSTEONICS CORP. HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 09/24/2004
K073076 HOWMEDICA OSTEONICS CORP. HOFFMANN LIGHT SYSTEM 02/15/2008
K033476 HOWMEDICA OSTEONICS CORP. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 01/20/2004
K041709 HOWMEDICA OSTEONICS CORP. NUMELOCK II SYSTEM 09/08/2004
K041001 HOWMEDICA OSTEONICS CORP. OMEGA 2 SYSTEM 07/01/2004
K081278 HOWMEDICA OSTEONICS CORP. OMEGA 3 TROCHANTERIC STABILIZING PLATE 05/29/2008
K020772 HOWMEDICA OSTEONICS CORP. OMEGA II SYSTEM 06/05/2002
K081284 HOWMEDICA OSTEONICS CORP. VARIAX DISTAL FIBULA PLATE 07/18/2008
K060613 HOWMEDICA OSTEONICS CORP. VARIAX LOCKING PLATE SYSTEM 04/21/2006
K940286 HOWMEDICA, INC. GAMMA LOCKING NAIL MODIFICATION 03/14/1994
K973321 HOWMEDICA, INC. HOFFMANN II COMPACT PERIARTICULAR CLAMP 11/20/1997
K920608 I. KLIMOV CO. AMERICA SYSTEM 06/19/1992
K070724 INTELLIGENT ORTHOPAEDICS LTD IOS EXTERNAL FIXATOR, MODEL 2-0-0 05/16/2007
K031875 INTER-OS TECHNOLOGIES INTER-OS LIMB LENGTHENER 10/22/2003
K152158 Jeil Medical Corporation ARIX Ankle System 09/28/2015
K100857 JOHN J RICCIO FUSION MEDICAL RING LOCK SYSTEM 05/27/2010
K072250 KINAMED, INC. SUPERCABLE GRIP AND PLATE SYSTEM 11/09/2007
K901234 KIRSCHNER MEDICAL CORP. KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE 10/04/1990
K854205 KIRSCHNER MEDICAL CORP. KIRSCHNER COMPRESSION HIP SCREW SYSTEM 11/19/1985
K842695 KIRSCHNER MEDICAL CORP. T.O.D. PLATE SYS STERILE 09/25/1984
K842681 KIRSCHNER MEDICAL CORP. T.O.D. PLATE SYSTEM 09/25/1984
K871249 KRONNER MEDICAL KRONNER BI-PLANER TIBIA EXTERNAL FIXATION 05/22/1987
K871248 KRONNER MEDICAL KRONNER COLLES-FOREARM EXTERNAL FIXATION 06/03/1987
K871247 KRONNER MEDICAL KRONNER UNIVERSAL FRAME EXTERNAL FIXATION 05/22/1987
K964458 LINK AMERICA, INC. ELLIS EXTERNAL MINI-FIXATOR SYSTEM 12/09/1996
K895507 LINK AMERICA, INC. LINK GIEBEL BLADE PLATE SYSTEM 03/13/1990
K093753 MDPO, LLC MDPO FRAME SYSTEM 08/26/2010
K843449 MECRON MEDICAL PRODUCTS, INC. AUTODYNAMIC COMPRESSION HIP SCREW-PLATE 10/22/1984
K901272 MED-TEK CORP. ORION BLADE PLATE FOR TIBIAL OSTEOTOMY 04/23/1990
K063487 MERETE MEDICAL GMBH MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE 01/22/2007
K102688 MERETE MEDICAL GMBH MERETE LOCKING BONE PLATE SYSTEM II 12/03/2010
K050457 MERETE MEDICAL GMBH MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM 03/14/2005
K090063 MERETE MEDICAL, INC. MERETE LOCKING BONE PLATE SYSTEM 04/22/2009
K070016 MERIDAN MEDICAL BLUE SHARK 04/02/2007
K012294 MILLENNIUM MEDICAL TECHNOLOGIES, INC. WRISTORE FIXATOR 03/04/2002
K040064 NEWMEDICAL TECHNOLOGY, INC. NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR 03/23/2004
K122777 NUTEK ORTHOPAEDICS, INC. NBX - NON BRIDGING EXTERNAL FIXATOR HAND 05/15/2013
K082833 NUTEK ORTHOPAEDICS, INC. NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER 02/05/2009
K905352 O'TEC CORP. BLADE PLATE 12/11/1990
K905346 O'TEC CORP. JEWETT HIP NAIL 12/11/1990
K905342 O'TEC CORP. LAG SCREW 12/11/1990
K905338 O'TEC CORP. SIDE PLATE 12/11/1990
K903250 ONYX MEDICAL CORP. BLADE PLATE 07/30/1990
K903251 ONYX MEDICAL CORP. JEWETT HIP NAIL 07/30/1990
K903246 ONYX MEDICAL CORP. SIDE PLATE 07/30/1990
K890989 ORIGIN MEDSYSTEMS, INC. DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR 04/05/1990
K170146 Orthofix Srl Galaxy UNYCO System 10/12/2017
K153233 ORTHOFIX SRL Galaxy UNYCO System 01/06/2016
K113770 ORTHOFIX SRL ORTHOFIX GALAXY FIXATION SYSTEM 09/04/2012
K142052 ORTHOFIX SRL ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT 12/05/2014
K141760 ORTHOFIX SRL ORTHOFIX GALAXY WRIST 12/08/2014
K141078 ORTHOFIX SRL ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) 09/02/2014
K152171 ORTHOFIX SRL Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 09/28/2015
K143125 Orthofix Srl Orthofix True Lok Hexapod System VI.3 12/10/2014
K170650 Orthofix Srl Orthofix TrueLok Hexapod System (TL-HEX) V2.0 05/10/2017
K051162 ORTHONETX, INC. GENEROS SB SMALL BONE DISTRACTION IMPLANT 07/19/2005
K971993 ORTHOPAEDIC DESIGNS, INC. ODI COMPRESSION HIP SCREW SYSTEM 11/12/1997
K863343 ORTHOPAEDIC DEVICE CORP. SUPERFIXATION(TM) 09/15/1986
K103015 ORTHOPAEDIC DEVICE RESEARCH CENTER ODRC-DYNAMIC HIP SCREW SYSTEM 04/13/2011
K171211 Orthopaedic Implant Company OIC External Fixation System 09/27/2017
K960014 ORTHOPAEDIC INNOVATIONS, INC. PRACTIFIX EXTERNAL FIXATION SYSTEM 03/18/1996
K170704 Pega Medical Inc. The Locking Pediatric Osteotomy Plate (LolliPOP) System 09/08/2017
K033856 PETER STEVENS, MD 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN 01/07/2005
K930156 PFIZER HOSPITAL PRODUCTS GROUP, INC. MEGA PLUS SUPER LAG SCREW 02/22/1994
K850403 PFIZER, INC. MEC DISTAL FEMORAL BOLT 07/15/1985
K850413 PFIZER, INC. MEC HIP BOLT 07/15/1985
K850443 PFIZER, INC. MEC ROD CONNECTOR 07/15/1985
K000734 PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 05/05/2000
K974409 PLUS ORTHOPEDICS FRIEDL GLIDING NAIL SYSTEM 02/19/1998
K033763 PLUS ORTHOPEDICS MODIFICATION TO SLIM GLIDING NAIL SYSTEM 12/18/2003
K020240 PLUS ORTHOPEDICS SLIM GLIDING NAIL SYSTEM 02/22/2002
K023851 PRECIMED, INC. PRECIMED HIP SCREW SYSTEM 01/28/2003
K091258 QFX TECHNOLOGIES, INC. EXTRAFIX EXTERNAL FIXATION SYSTEM 07/24/2009
K111993 QUANTUM MEDICAL CONCEPTS, LLC. FRAMEWALKER 10/24/2011
K101759 QUANTUM MEDICAL CONCEPTS, LLC. QUANTUM RING FIXATION SYSTEM MODEL ISF 10/22/2010
K052005 R&R MEDICAL, INC. R&R EXTERNAL FIXATION SYSTEM 09/06/2005
K043174 R&R MEDICAL, INC. STEALTH FUSION SYSTEM, MODEL RR 1000 02/07/2005
K051017 R-X-FIX R-X-FIX EXTERNAL FIXATOR 06/29/2005
K110965 RENOVIS SURGICAL TECHNOLOGIES, LLC RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM 05/11/2011
K895241 RICHARDS MEDICAL CO., INC. INTRAMEDULLARY HIP SCREW 01/04/1990
K870961 RICHARDS MEDICAL CO., INC. RICHARDS EXTERNAL FIXATION SYSTEM 03/19/1987
K020311 RIGID FX ORTHOPEDICS, INCORPORATED CLEARVIEW WRIST FIXATOR 04/29/2002
K022423 RIGID FX ORTHOPEDICS, INCORPORATED EXTERNAL FIXATION RING 09/17/2002
K043289 SIGNAL MEDICAL CORP. E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT 02/11/2005
K071394 SMALL BONE INNOVATIONS INC. MODIFICATION TO:SBI RINGFIX 06/29/2007
K093550 SMALL BONE INNOVATIONS, INC. MINI RAIL EXTERNAL FIXATOR SYSTEM 01/07/2010
K962808 SMITH & NEPHEW RICHARDS, INC. ILIZAROV EXTERNAL FIXATION SYSTEM 08/19/1996
K921786 SMITH & NEPHEW RICHARDS, INC. INTRAMEDULLARY HIP SCREW 07/17/1992
K954712 SMITH & NEPHEW RICHARDS, INC. INTRAMEDULLARY HIP SCREW (MODIFICATION) 10/31/1995
K912162 SMITH & NEPHEW RICHARDS, INC. INTRAMEDULLARY HIP SCREW, MODIFICATION 08/14/1991
K920024 SMITH & NEPHEW RICHARDS, INC. RIHARDS TITANIUM HALF PIN 01/21/1992
K142520 Smith & Nephew, Inc Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software 11/20/2014
K092002 SMITH & NEPHEW, INC. AFGHAN EXTERNAL FIXATOR 12/10/2009
K031181 SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEMS 07/14/2003
K050849 SMITH & NEPHEW, INC. HA COATED LAG SCREW 05/04/2005
K042436 SMITH & NEPHEW, INC. IIIZAROV PULLEY SYSTEM 10/07/2004
K130479 SMITH & NEPHEW, INC. ILIZAROV DRILL TIP WIRES 05/14/2013
K042312 SMITH & NEPHEW, INC. JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE 09/24/2004
K100795 SMITH & NEPHEW, INC. JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING 09/02/2010
K072212 SMITH & NEPHEW, INC. JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE 03/07/2008
K093047 SMITH & NEPHEW, INC. SMITH & NEPHEW CIRCULAR FIXATION SYSTEM 09/27/2010
K993289 SMITH & NEPHEW, INC. SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM 12/20/1999
K090926 SMITH & NEPHEW, INC. SMITH & NEPHEW RAIL SYSTEM 06/08/2009
K110069 SMITH & NEPHEW, INC. SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE 02/08/2011
K970748 SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM 05/09/1997
K911021 SPORT SERVICE, INC. PLATE BLADE WITH CURSOR OF L'UNION 05/29/1991
K051957 STERILEMED INC. REPROCESSED EXTERNAL FIXATION DEVICE 09/21/2005
K081342 STERILMED, INC. REPROCESSED EXTERNAL FIXATION ACCESSORIES 08/13/2008
K081586 STERILMED, INC. REPROCESSED EXTERNAL FIXATION DEVICE 08/18/2008
K083636 STERILMED, INC. REPROCESSED EXTERNAL FIXATION DEVICE 03/02/2009
K883715 STRAUB CLINIC AND HOSPITAL AXIAL COMPRESSION SCREW 09/22/1988
K870786 STRAUB CLINIC AND HOSPITAL AXIAL COMPRESSION SCREW 06/01/1987
K122284 STRYKER CORP. HOFFMANN 3 10/24/2012
K111786 STRYKER CORP. HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM 01/26/2012
K121252 STRYKER CORP. HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM 07/25/2012
K113327 STRYKER CORP. HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM 03/29/2012
K161753 STRYKER GMBH Hoffman LRF System 11/15/2016
K153377 Stryker GmbH Hoffmann LRF (Limb Reconstruction Frame) System 04/11/2016
K163656 Stryker GmbH Hoffmann LRF System 04/14/2017
K153415 STRYKER SUSTAINABILITY SOLUTIONS Reprocessed Stryker External Fixation Devices 01/13/2016
K130334 Stryker Trauma AG HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) 05/03/2013
K130907 Stryker Trauma AG HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM 06/10/2013
K140961 Stryker Trauma AG HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM 11/10/2014
K083582 SURGICAL IMPLANT GENERATION NETWORK (SIGN) SIGN HIP CONSTRUCT (SHC), MODEL: 701 08/26/2009
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K033995 SYNTHES (USA) 3.5 MM LCP DISTAL HUMERUS SYSTEM 03/01/2004
K010344 SYNTHES (USA) ADJUSTABLE LARGE FIXATOR SYSTEM 05/03/2001
K000684 SYNTHES (USA) SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM 04/28/2000
K984498 SYNTHES (USA) SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM 02/18/1999
K051600 SYNTHES (USA) SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM 07/27/2005
K043039 SYNTHES (USA) SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE 01/18/2005
K010766 SYNTHES (USA) SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE 06/12/2001
K041911 SYNTHES (USA) SYNTHES (USA) LCP CURVED PLATES 09/08/2004
K033556 SYNTHES (USA) SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM 01/13/2004
K051049 SYNTHES (USA) SYNTHES (USA) LOW-PROFILE WRIST FIXATOR 07/13/2005
K011034 SYNTHES (USA) SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM 06/27/2001
K033411 SYNTHES (USA) SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS 11/26/2003
K031573 SYNTHES (USA) SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE 06/06/2003
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K000682 SYNTHES (USA) SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM 05/01/2000
K042895 SYNTHES (USA) SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES 11/16/2004
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K031724 SYNTHES (USA) SYNTHES SMALL COBINATION CLAMP-MR SAFE 07/14/2003
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K150640 WRIGHT MEDICAL TECHNOLOGY, INC. RX-FIX Mini Rail External Fixator 12/01/2015
K180832 Wright Medical Technology, Inc. SALVATION External Fixation System 06/06/2018
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