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Orthopedic

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

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RecordFirmDate
SYNVISC (HYLAN G-F 20) (P940015/S009)Sanofi Genzyme Corp.2003-03-14
EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM (P900009/S016)Bioventus, LLC2003-02-21
TRIDENT SYSTEM (P000013)Howmedica Osteonics Corp.2003-02-03
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001)Ceramtec GmbH2003-02-03
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
LCS TOTAL KNEE SYSTEM (P830055/S083)Depuy, Inc.2002-12-17
MODEL SPF-60 SPINAL FUSION STIMULATOR (P850035/S029)Ahp Eos Buyer, Inc.2002-12-06
AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S002)Medtronic Sofamor Danek USA, Inc.2002-12-03
EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S014)Bioventus, LLC2002-11-18
COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S012)Neucoll, Inc.2002-10-10
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S001)Medtronic Sofamor Danek USA, Inc.2002-10-04
LCS TOTAL KNEE SYSTEM (P830055/S082)Depuy, Inc.2002-10-04
AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S001)Medtronic Sofamor Danek USA, Inc.2002-08-13
EBI BONE HEALING SYSTEM - MODEL 2001 (P790002/S022)Ahp Eos Buyer, Inc.2002-08-13
LT-CAGE TAPERED FUSION DEVICE (P970015/S020)Sofamor Danek2002-08-12
SIEMENS SONOCUR BASIC SYSTEM (P010039)Siemens Medical Solutions USA, Inc.2002-07-19
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058)Medtronic Sofamor Danek USA, Inc.2002-07-02
COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S011)Neucoll, Inc.2002-07-02
BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM (P980048/S002)Sulzer Spine-Tech2002-06-19
AFFINITY (TM) CAGE SYSTEM (P000028)Medtronic Sofamor Danek USA, Inc.2002-06-13
PRO OSTEON 500 BONE GRAFT SUBSTITUTE (P860005/S012)Interpore Intl.2002-05-31
BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE (P950002/S007)Zimmer Spine, Inc.2002-05-01
SYNVISC(HYLAN G-F 20) (P940015/S007)Sanofi Genzyme Corp.2002-04-26
RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012)Stryker Spine2002-04-02
EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S015)Bioventus, LLC2002-03-29
LUMBAR I/F CAGE(R) SYSTEM (P960025/S008)Depuy Spine, Inc.2002-03-01
ASCENSION MCP (P000057/S001)Smith & Nephew, Inc.2002-02-08
LCS TOTAL KNEE SYSTEM (P830055/S081)Depuy, Inc.2002-02-05
LUMBAR I/F CAGE SYSTEM (P960025/S009)Depuy Spine, Inc.2002-02-04
LCS UNI TOTAL KNEE SYSTEM (P910016/S012)Depuy, Inc.2002-02-04
DORNIER EPOS ULTRA (P000048)Dornier Medtech America, Inc.2002-01-15
ASCENSION MCP (P000057)Smith & Nephew, Inc.2001-11-19
BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR (P850022/S013)Ahp Eos Buyer, Inc.2001-10-10
LCS TOTAL KNEE SYSTEM (P830055/S080)Depuy, Inc.2001-10-03
LUMBAR I/F CAGE SYSTEM (P960025/S007)Depuy Spine, Inc.2001-09-17
EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) (P900009/S013)Bioventus, LLC2001-09-04
NATURAL-KNEE AND NATURAL-KNEE II (P940002/S005)Sulzermedica2001-08-01
HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT (P960047/S003)Howmedica Osteonics Corp.2001-07-25
DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE (P970015/S019)Sofamor Danek2001-07-19
LCS TOTAL KNEE SYSTEM (P830055/S079)Depuy, Inc.2001-07-06
LCS TOTAL KNEE SYSTEM (P830055/S078)Depuy, Inc.2001-06-13
OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS (P910066/S016)Djo, LLC2001-05-18
LUMBAR I/F CAGE SYSTEM (P960025/S006)Depuy Spine, Inc.2001-05-14
BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048/S001)Sulzer Spine-Tech2001-05-02
BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM (P980048)Sulzer Spine-Tech2001-04-20
LCS TOTAL KNEE SYSTEM (P830055/S075)Depuy, Inc.2001-04-17
BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM (P950002/S009)Zimmer Spine, Inc.2001-04-03
PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR (P850007/S026)Orthofix, Inc.2001-03-09
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S002)Depuy Spine, Inc.2001-02-28
EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S012)Bioventus, LLC2001-02-21
SUPARTZ FX (P980044)Seikagaku Corp.2001-01-24
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S004)Depuy Spine, Inc.2001-01-12
SURGICAL SIMPLEX P BONE CEMENT (N17004/S013)Howmedica Corp.2000-12-15
INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE (P970015/S017)Sofamor Danek2000-12-13
LCS TOTAL KNEE SYSTEM (P830055/S077)Depuy, Inc.2000-11-13
LCS TOTAL KNEE SYSTEM (P830055/S076)Depuy, Inc.2000-11-08
HEALTHTRONICS OSSATRON (P990086)Sanuwave, Inc.2000-10-12
LORDOTEC(TM) TAPERED FUSION DEVICE (P970015/S010)Sofamor Danek2000-09-28
SPF IMPLANTABLE BONE GROWTH STIMULATOR (P850035/S025)Ahp Eos Buyer, Inc.2000-09-27
SYNVISC (HYLAN G-F 20) (P940015/S005)Sanofi Genzyme Corp.2000-09-12
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S005)Depuy Spine, Inc.2000-09-08
EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S011)Bioventus, LLC2000-09-08
HYALGAN (P950027/S004)Fidia Farmaceutici S.P.A.2000-08-30
SPINALOGIC BONE GROWTH STIMULATOR (P910066/S015)Djo, LLC2000-08-23
INTERFIX THREADED FUSION DEVICE (P970015/S014)Sofamor Danek2000-08-09
INTER FIX THREADED FUSION DEVICE (P970015/S013)Sofamor Danek2000-07-11
OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S043)Ahp Eos Buyer, Inc.2000-06-23
SPF SPINAL FUSION STIMULATOR (P850035/S028)Ahp Eos Buyer, Inc.2000-06-23
SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000 (P900009/S009)Bioventus, LLC2000-06-22
LCS TOTAL KNEE SYSTEM (P830055/S074)Depuy, Inc.2000-06-22
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012)Howmedica Corp.2000-06-20
INTER FIX III THREADED FUSION DEVICE (P970015/S011)Sofamor Danek2000-06-06
PHYSIO-STIM BONE GROWTH STIMULATOR (P850007/S025)Orthofix, Inc.2000-05-31
LCS TOTAL KNEE SYSTEM (P830055/S073)Depuy, Inc.2000-05-19
SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM) (P900009/S010)Bioventus, LLC2000-05-10
OSTEOGEN(R) D40 IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S042)Ahp Eos Buyer, Inc.2000-05-10
OSTEONICS CONSTRAINED ACETABULAR INSERT (P960047/S002)Howmedica Osteonics Corp.2000-05-01
LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES (P830055/S072)Depuy, Inc.2000-04-28
NATURAL KNEE & NATURAL KNEE II (P940002/S003)Sulzermedica2000-04-18
EXOGEN 3000 (P900009/S008)Bioventus, LLC2000-04-14
INTER FIX RP THREADED FUSION DEVICE (P970015/S009)Sofamor Danek2000-04-12
INTER FIX RP THREADED FUSION DEVICE (P970015/S005)Sofamor Danek2000-04-12
INTER FIX THREADED FUSION DEVICE (P970015/S008)Sofamor Danek2000-04-12
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S003)Depuy Spine, Inc.2000-04-10
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
LCS TOTAL KNEE SYSTEM (P830055/S070)Depuy, Inc.2000-03-30
LCS(R) TOTAL KNEE SYSTEM DESIGN MODIFICATION TO ROTATING PLATFORM BEARINGS (P830055/S069)Depuy, Inc.2000-03-16
ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR (P910066/S014)Djo, LLC2000-03-09
PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS (P850007/S020)Orthofix, Inc.2000-03-09
LCS TOTAL KNEE SYSTEM (P830055/S068)Depuy, Inc.2000-03-06
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000 (P900009/S006)Bioventus, LLC2000-02-22
EBI BONE HEALING SYSTEM-MODEL 1026 (P790002/S021)Ahp Eos Buyer, Inc.1999-12-29
S-ROM POLY-DAIL CONSTRAINED LINER (P960054/S003)Depuy, A Johnson & Johnson Co.1999-12-22
BAK/L INTERBODY FUSION SYSTEM (P950002/S008)Zimmer Spine, Inc.1999-12-20
SYNVISC (HYLAN G-F 20) (P940015/S003)Sanofi Genzyme Corp.1999-12-20
HYALGAN(R) (P950027/S003)Fidia Farmaceutici S.P.A.1999-12-18
HYALGAN(R) (P950027/S002)Fidia Farmaceutici S.P.A.1999-12-18
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S011)Djo, LLC1999-12-17
S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER (P960054/S002)Depuy, A Johnson & Johnson Co.1999-12-07
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