FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K071852 |
AAP IMPLANTATE AG |
AAP APS SYSTEM |
08/29/2007 |
K101170 |
ACUTE INNOVATIONS LLC |
ACUTE INNOVATIONS STERNAL FIXATION SYSTEM |
09/17/2010 |
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 |
K200491 |
Aike (Shanghai) Medical Instrument Co., Ltd. |
Bfix Orthopedic External Fixator Systems |
01/05/2021 |
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 |
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 |
K091619 |
ANGLEFIX |
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) |
09/08/2009 |
K200123 |
Arrowhead DE, LLC |
Accessories for the SixFix« Hexapod Fixator |
09/22/2020 |
K162032 |
Arrowhead DE, LLC |
Arrowhead Mini-Rail Fixator |
02/21/2017 |
K190069 |
Arrowhead DE, LLC |
SixFixÖ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) |
05/14/2019 |
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 |
K181528 |
Austin Miller Trauma LLC |
Austin Miller Large External Fixation System |
02/28/2019 |
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 |
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 |
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 |
K231922 |
Depuy Synthes |
DEPUY SYNTHES MAXFRAME AUTOSTRUT System |
07/26/2023 |
K972629 |
DEPUY, INC. |
DEPUY AE TK2 HIP SCREW SYSTEM |
10/09/1997 |
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 |
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 |
K011697 |
EBI, L.P. |
EBI XFIX ACCESS PELVIC FIXATOR |
06/27/2001 |
K013540 |
EBI, L.P. |
EBI XFIX ACCESS PELVIC FIXATOR |
11/20/2001 |
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 |
K000319 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
02/25/2000 |
K012024 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
07/25/2001 |
K013378 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
11/08/2001 |
K021091 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
05/03/2002 |
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 |
K031919 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
09/04/2003 |
K040935 |
EBI, L.P. |
EBI XFIX DFS SYSTEM |
07/06/2004 |
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 |
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 |
K033635 |
EBI, L.P. |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
12/03/2003 |
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 |
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 |
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 |
K200343 |
GLW Medical Innovation |
FusionFrame Ring Lock System |
09/14/2020 |
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 |
K961213 |
HOWMEDICA CORP. |
ALTA DOME AND PLUNGER (MEC HIP BOLT) |
06/13/1996 |
K955306 |
HOWMEDICA CORP. |
OMEGA+ COMPRESSION SCREW SYSTEM |
04/10/1996 |
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 |
K973321 |
HOWMEDICA, INC. |
HOFFMANN II COMPACT PERIARTICULAR CLAMP |
11/20/1997 |
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 |
K173883 |
Life Spine Inc. |
External Fixation System |
09/07/2018 |
K964458 |
LINK AMERICA, INC. |
ELLIS EXTERNAL MINI-FIXATOR SYSTEM |
12/09/1996 |
K093753 |
MDPO, LLC |
MDPO FRAME SYSTEM |
08/26/2010 |
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 |
K181630 |
New Standard Device DBA Metalogix |
Revolution External Plating System |
05/29/2019 |
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 |
K192181 |
NuVasive Specialized Orthopedics, Inc. |
PRECICE Plating System |
11/07/2019 |
K153233 |
ORTHOFIX SRL |
Galaxy UNYCO System |
01/06/2016 |
K170146 |
Orthofix Srl |
Galaxy UNYCO System |
10/12/2017 |
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 |
K212044 |
Orthofix SRL |
TrueLok Evo |
11/05/2021 |
K051162 |
ORTHONETX, INC. |
GENEROS SB SMALL BONE DISTRACTION IMPLANT |
07/19/2005 |
K213905 |
OrthoNovis, Inc. |
ONX Large External Fixation System |
08/25/2022 |
K971993 |
ORTHOPAEDIC DESIGNS, INC. |
ODI COMPRESSION HIP SCREW SYSTEM |
11/12/1997 |
K103015 |
ORTHOPAEDIC DEVICE RESEARCH CENTER |
ODRC-DYNAMIC HIP SCREW SYSTEM |
04/13/2011 |
K171211 |
Orthopaedic Implant Company |
OIC External Fixation System |
09/27/2017 |
K183682 |
Orthopaedic Implant Company |
OIC External Fixation System |
04/08/2019 |
K211112 |
Orthopaedic Implant Company |
OIC External Fixation System |
05/05/2021 |
K960014 |
ORTHOPAEDIC INNOVATIONS, INC. |
PRACTIFIX EXTERNAL FIXATION SYSTEM |
03/18/1996 |
K220809 |
OrthoPediatrics Corp. |
Drive Rail System |
04/08/2022 |
K223786 |
OrthoPediatrics Corp. |
Orthex External Fixation System |
02/10/2023 |
K191241 |
OrthoSpin |
AutoStrut |
08/14/2019 |
K202810 |
OrthoSpin Ltd |
AutoStrut G2 |
01/06/2021 |
K212895 |
Paragon 28, Inc |
Paragon 28 External Ring Fixation System |
11/08/2021 |
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 |
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 |
K051017 |
R-X-FIX |
R-X-FIX EXTERNAL FIXATOR |
06/29/2005 |
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 |
K110965 |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM |
05/11/2011 |
K020311 |
RIGID FX ORTHOPEDICS, INCORPORATED |
CLEARVIEW WRIST FIXATOR |
04/29/2002 |
K022423 |
RIGID FX ORTHOPEDICS, INCORPORATED |
EXTERNAL FIXATION RING |
09/17/2002 |
K200518 |
S H Pitkar Orthotools Pvt Ltd |
Pitkar External Fixation System - Rail Mechanism |
07/29/2020 |
K200728 |
S H Pitkar Orthotools Pvt Ltd. |
Pitkar DeftFix System |
10/06/2020 |
K190486 |
S H Pitkar Orthotools Pvt Ltd. |
Pitkar External Fixation System |
10/16/2019 |
K202833 |
Sequel Medical Inc. |
Sequel External Fixation Device |
01/19/2021 |
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 |
K201253 |
Smith & Nephew |
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation |
12/08/2020 |
K962808 |
SMITH & NEPHEW RICHARDS, INC. |
ILIZAROV EXTERNAL FIXATION SYSTEM |
08/19/1996 |
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 |
K202762 |
Smith & Nephew, Inc. |
Circular Fixation with Balanced Cable Transport |
11/16/2020 |
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 |
K210953 |
Smith & Nephew, Inc. |
SMART Taylor Spatial Frame |
07/29/2021 |
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 |
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 |
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 |
K182968 |
Stryker GmbH |
Hoffmann LRF System |
01/25/2019 |
K203568 |
Stryker GmbH |
Hoffmann LRF System |
02/01/2021 |
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 |
K180580 |
Surgical Instrument Service and Savings Inc |
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices |
07/27/2018 |
K171911 |
Surgical Instrument Service and Savings Inc |
Medline ReNewal Reprocessed Synthes External Fixation Systems |
11/09/2017 |
K983873 |
SYNTEC SCIENTIFIC CORP. |
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM |
12/30/1998 |
K984364 |
SYNTEC SCIENTIFIC CORP. |
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 |
03/02/1999 |
K122455 |
SYNTHES |
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM |
04/11/2013 |
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 |
K010518 |
SYNTHES (USA) |
SYNTHES ANTEROLATERAL CALCANEAL PLATE |
05/23/2001 |
K974537 |
SYNTHES (USA) |
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM |
02/18/1998 |
K973017 |
SYNTHES (USA) |
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP |
10/16/1997 |
K092190 |
SYNTHES (USA) |
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS |
05/11/2010 |
K090658 |
SYNTHES (USA) |
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL |
03/03/2010 |
K082650 |
SYNTHES (USA) |
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL |
11/18/2008 |
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 |
K040258 |
SYNTHES (USA) |
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE |
03/23/2004 |
K961350 |
SYNTHES (USA) |
SYNTHES MINI EXTERNAL FIXATOR |
06/28/1996 |
K033158 |
SYNTHES (USA) |
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES |
11/05/2003 |
K031724 |
SYNTHES (USA) |
SYNTHES SMALL COBINATION CLAMP-MR SAFE |
07/14/2003 |
K031725 |
SYNTHES (USA) |
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM |
06/24/2003 |
K962484 |
SYNTHES (USA) |
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) |
09/05/1996 |
K023941 |
SYNTHES (USA) |
SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
01/23/2003 |
K182154 |
Synthes (USA) Products, LLC |
Depuy Synthes Femoral Neck System |
10/16/2018 |
K211313 |
Synthes (USA) Products, LLC |
MAXFRAME Multi-Axial Correction System (aka MAXFRAME) |
05/25/2021 |
K161417 |
SYNTHES USA, LLC |
DePuy Synthes MAXFRAME Multi-Axial Correction System |
11/10/2016 |
K170482 |
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S |
Spider Frame External Fixation System |
09/27/2017 |
K101338 |
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
NEWFIX EXTERNAL FIXATION SYSTEM |
03/14/2011 |
K122210 |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
NEWFIX EXTERNAL FIXATION SYSTEM |
04/19/2013 |
K113123 |
THE ORTHOPAEDIC IMPLANT COMPANY |
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM |
01/12/2012 |
K063551 |
TORNIER |
AEQUALIS HUMERAL PLATE |
12/22/2006 |
K060545 |
TORNIER |
UNITY HUMERAL PLATE |
04/21/2006 |
K031687 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
04/30/2004 |
K051180 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
07/22/2005 |
K051616 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
09/06/2005 |
K053051 |
VANGUARD MEDICAL CONCEPTS, INC. |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
12/22/2005 |
K151881 |
VILEX IN TENNESSEE, INC |
X-Fix Line Additions |
03/24/2016 |
K212552 |
Vilex LLC |
Correx Software |
10/12/2021 |
K052196 |
VILEX, INC. |
VILEX X-FIX |
11/22/2005 |
K202143 |
Vilex, LLC |
Dynex Micro |
09/11/2020 |
K202054 |
Vilex, LLC |
Dynex Ring Fixation System, Diametrix Ring Fixation System |
08/24/2020 |
K964880 |
WALTER ABENDSCHEIN, M.D. |
VARI-ANGLE HIP SCREW (VHS) SYSTEM |
10/16/1997 |
K011603 |
WALTER ABENDSCHEIN, M.D. |
VHS PEDIATRIC HIP SCREW SYSTEM |
08/15/2001 |
K991806 |
WALTER ABENDSCHEIN, M.D. |
VHS SUPRACONDYLAR PLATE SYSTEM |
08/06/1999 |
K193368 |
WishBone Medical, Inc. |
Smart Correction System |
09/18/2020 |
K231461 |
WishBone Medical, Inc. |
Smart Correction System (HA Half Pins) |
06/16/2023 |
K221366 |
WishBone Medical, Inc. |
Smart Correction System Rings and Compatible HA-Coated Half Pins |
06/06/2022 |
K162033 |
WRIGHT MEDICAL |
SALVATION External Fixation System |
03/06/2017 |
K042358 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LOCON VLS DISTAL RADIUS PLATE SYSTEM |
10/07/2004 |
K962251 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MEDOFF SLIDING PLATE (PROPOSED NAME) |
01/22/1997 |
K150640 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RX-FIX Mini Rail External Fixator |
12/01/2015 |
K150004 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SALVATION External Fixation System |
03/04/2015 |
K180832 |
Wright Medical Technology, Inc. |
SALVATION External Fixation System |
06/06/2018 |
K152045 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SALVATION« External Fixation System |
08/21/2015 |
K153635 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SALVATION(R) External Fixation System |
01/13/2016 |
K100137 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES |
06/10/2010 |
K143220 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SIDEKICK EZ FRAME External Fixation System |
01/08/2015 |
K130044 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM |
04/05/2013 |
K080071 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SIDEKICK RAIL FIXATOR |
02/07/2008 |
K151907 |
ZIMMER, INC. |
Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables |
12/30/2015 |
K152484 |
ZIMMER, INC. |
FastFrame External Fixation System - Distal Radius |
12/04/2015 |
K151992 |
ZIMMER, INC. |
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control |
11/02/2015 |
K152755 |
Zimmer, Inc. |
FastFrame External Fixation System-Ankle Spanning |
12/21/2015 |
K954555 |
ZIMMER, INC. |
VERSA-FX FEMORAL FIXATION SYSTEM |
01/26/1996 |
K150818 |
ZIMMER, INC. |
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System |
05/01/2015 |
K042761 |
ZIMMER, INC. |
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES |
11/17/2004 |
K141697 |
ZIMMER, INC. |
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM |
09/18/2014 |
K131413 |
ZIMMER, INC. |
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM |
01/28/2014 |