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Orthopedic

2,480 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01
LCS TOTAL KNEE SYSTEM (P830055/S067)Depuy, Inc.1999-11-22
LCS TOTAL KNEE SYSTEM (P830055/S060)Depuy, Inc.1999-11-10
S-ROM POLY-DIAL CONSTRAINED LINER (P960054/S004)Depuy, A Johnson & Johnson Co.1999-11-10
LCS TOTAL KNEE SYSTEM (P830055/S065)Depuy, Inc.1999-10-07
LCS POSTERIOR STABILIZED TIBIAL INSERTS (P830055/S066)Depuy, Inc.1999-10-07
LSC REVISION SYSTEM (P830055/S064)Depuy, Inc.1999-10-04
RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION (P950019/S008)Stryker Spine1999-10-04
SPINALPAK(R) STIMULATOR (P850022/S009)Ahp Eos Buyer, Inc.1999-09-24
DEPUY 3 BONE CEMENT (P960001/S006)Depuy, Inc.1999-09-20
DEPUY 1 AND ENDURANCE BONE CEMENTS (P960001/S008)Depuy, Inc.1999-09-01
DEPUY 3 BONE CEMENT (P960001/S005)Depuy, Inc.1999-08-26
SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S007)Bioventus, LLC1999-08-25
LCS TOTAL KNEE SYSTEM (P830055/S063)Depuy, Inc.1999-08-05
ORTHOPAK BONE GROWTH STIMULATOR (P850022/S012)Ahp Eos Buyer, Inc.1999-07-26
LCS TOTAL KNEE SYSTEM (P830055/S062)Depuy, Inc.1999-07-22
LUMBAR I/F CAGE WITH VSP SPINAL SYSTEM (P960025/S001)Depuy Spine, Inc.1999-07-16
DEPUY 3 BONE CEMENT (P960001/S004)Depuy, Inc.1999-07-13
SYNVISC (HYLAN G-F 20) (P940015/S004)Sanofi Genzyme Corp.1999-05-26
PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES (P860005/S011)Interpore Intl.1999-05-25
LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL (P830055/S061)Depuy, Inc.1999-05-19
NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD) (P970015/S002)Sofamor Danek1999-05-14
INTER FIX THREADED FUSION DEVICE (P970015)Sofamor Danek1999-05-14
INTER FIX THREADED FUSION DEVICE (P970015/S003)Sofamor Danek1999-05-14
NOVUS (TM) LC INTERBODY FUSION DEVICE (P970015/S001)Sofamor Danek1999-05-14
ORTHOLOGIC 1000 BONE GROWTH STIMULATOR/PATIENT REGISTRY MARKETING BROCHURE (P910066/S013)Djo, LLC1999-04-20
EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S024)Ahp Eos Buyer, Inc.1999-04-07
RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION (P950019/S007)Stryker Spine1999-03-19
LCS(R)TOTAL KNEE SYSTEM (P910016/S011)Depuy, Inc.1999-03-04
LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO (P830055/S058)Depuy, Inc.1999-02-25
SYNVISC (HYLAN G-F 20) (P940015/S002)Sanofi Genzyme Corp.1999-02-19
RAY FUSION THREADED CAGE (TFC) DEVICE (P950019/S006)Stryker Spine1999-02-05
BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS (P960025)Depuy Spine, Inc.1999-02-02
EBI BONE HEALING SYSTEM (P790002/S020)Ahp Eos Buyer, Inc.1999-01-26
NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010)Synthes (Usa)1998-12-23
COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S010)Neucoll, Inc.1998-12-07
SYNVISC (HYLAN G-F 20 (P940015/S001)Sanofi Genzyme Corp.1998-11-05
SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM (P850007/S024)Orthofix, Inc.1998-11-03
RAY TFC DEVICE INSTRUMENTATION (P950019/S005)Stryker Spine1998-10-29
ORTHOSET BONE CEMENT (N18466/S023)Depuy, Inc.1998-10-21
ORTHOLOGIC 1000 SC (P910066/S012)Djo, LLC1998-10-16
OSTEOPAL (P810020/S005)Smith & Nephew Richards, Inc.1998-10-15
DEPUY 3 BONE CEMENT (P960001/S007)Depuy, Inc.1998-08-27
RAY TFC DEVICE WITH INSTRUMENTATION (P950019/S004)Stryker Spine1998-08-27
PHYSIO-STIM BONE GROWTH STIMULATOR (P850007/S023)Orthofix, Inc.1998-08-14
PHYSIO-STIM BONE GROWTH STIMULATOR (P850007/S022)Orthofix, Inc.1998-08-13
PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004)Smith & Nephew Richards, Inc.1998-07-30
EBI BONE HEALING SYSTEM(R) (P790002/S019)Ahp Eos Buyer, Inc.1998-07-27
EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S041)Ahp Eos Buyer, Inc.1998-07-24
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S009)Djo, LLC1998-07-14
ORTHOPAK II BONE GROWTH STIMULATOR (P850022/S011)Ahp Eos Buyer, Inc.1998-07-14
RAY TFC DEVICE WITH INSTRUMENTATION (20MM) (P950019/S003)Stryker Spine1998-06-17
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S008)Djo, LLC1998-06-12
RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION (P950019/S002)Stryker Spine1998-06-08
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO (P830055/S059)Depuy, Inc.1998-05-14
SPINAL-STIM LITE SPINAL FUSION SYSTEM (P850007/S021)Orthofix, Inc.1998-05-14
LCS TOTAL KNEE SYSTEM (P830055/S056)Depuy, Inc.1998-05-14
BAK INTERBODY FUSION SYSTEM (P950002/S006)Zimmer Spine, Inc.1998-05-12
LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO (P830055/S057)Depuy, Inc.1998-05-01
OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR (P790005/S040)Ahp Eos Buyer, Inc.1998-05-01
EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S023)Ahp Eos Buyer, Inc.1998-05-01
PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES (P860005/S009)Interpore Intl.1998-04-28
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S007)Djo, LLC1998-04-03
OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047/S001)Howmedica Osteonics Corp.1998-04-02
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011)Howmedica Corp.1998-03-18
EBI BONE HEALING SYSTEM(R) (P790002/S015)Ahp Eos Buyer, Inc.1998-03-12
NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S053)Depuy, Inc.1998-02-12
BAK INTERBODY FUSION SYSTEM (P950002/S005)Zimmer Spine, Inc.1998-02-06
ENDURANCE BONE CEMENT (P960001/S003)Depuy, Inc.1998-01-27
LCS(R)TOTAL KNEE SYSTEM (P910016/S009)Depuy, Inc.1998-01-15
LCS(R)TOTAL KNEE SYSTEM (P910016/S010)Depuy, Inc.1998-01-15
PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE (P860005/S010)Interpore Intl.1998-01-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010)Howmedica Corp.1997-11-13
ENDURANCE BONE CEMENT (P960001/S001)Depuy, Inc.1997-11-12
OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S048)Zimmer, Inc.1997-10-28
NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S002)Sulzermedica1997-10-16
BAK INTERBODY FUSION SYSTEM (P950002/S003)Zimmer Spine, Inc.1997-10-15
SPINAL-STIM LITE SPINAL FUSION SYSTEM (P850007/S019)Orthofix, Inc.1997-09-19
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S008)Interpore Intl.1997-09-11
OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S049)Zimmer, Inc.1997-09-05
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009)Howmedica Corp.1997-08-08
SYNVISC ONE (P940015)Sanofi Genzyme Corp.1997-08-08
BAK INTERBODY FUSION SYSTEM (P950002/S001)Zimmer Spine, Inc.1997-07-22
OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR (P790005/S039)Ahp Eos Buyer, Inc.1997-07-17
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II (P850035/S021)Ahp Eos Buyer, Inc.1997-07-17
HYALGAN(R) (P950027/S001)Fidia Farmaceutici S.P.A.1997-07-08
BAK INTERBODY FUSION SYSTEM (P950002/S004)Zimmer Spine, Inc.1997-06-30
ORTHOLOGIC 1000 BONE GROWTH STIMULATOR (P910066/S004)Djo, LLC1997-06-25
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19
S-ROM POLY-DIAL CONSTRAINED LINER (P960054)Depuy, A Johnson & Johnson Co.1997-06-19
OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047)Howmedica Osteonics Corp.1997-06-13
EBI BONE HEALING SYSTEM(R) (P790002/S018)Ahp Eos Buyer, Inc.1997-06-11
NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S055)Depuy, Inc.1997-06-11
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S007)Interpore Intl.1997-05-30
HYALGAN(R) (P950027)Fidia Farmaceutici S.P.A.1997-05-28
BAK INTERBODY FUSION SYSTEM (P950002/S002)Zimmer Spine, Inc.1997-05-09
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S005)Djo, LLC1997-05-09
NEW JERSEY LCS TOTAL KNEE SYSTEM (P830055/S054)Depuy, Inc.1997-04-30
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