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Orthopedic

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

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RecordFirmDate
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S010)DePuy Orthopaedics, Inc.2007-11-14
CORMET HIP RESURFACING SYSTEM (P050016/S002)Corin USA2007-11-02
ORTHOVISC SODIUM HYALURONATE (P030019/S009)Anika Therapeutics, Inc.2007-10-26
CORMET HIP RESURFACING SYSTEM (P050016/S001)Corin USA2007-10-18
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S006)Smith & Nephew, Inc.2007-10-12
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S023)Medtronic Sofamor Danek USA, Inc.2007-10-05
INFUSE BONE GRAFT (P000054/S011)Medtronic Sofamor Danek USA, Inc.2007-10-05
X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S007)Medtronic Sofamor Danek, Inc.2007-10-04
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S004)Smith & Nephew, Inc.2007-10-01
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
PRESTIGE CERVICAL DISC (P060018/S001)Medtronic Sofamor Danek, Inc.2007-09-18
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S016)Biomet Manufacturing Corp2007-09-12
IN MOTION ARTIFICIAL DISC (P040006/S004)Depuy Spine, Inc.2007-09-05
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S009)DePuy Orthopaedics, Inc.2007-09-03
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S006)Biomet Manufacturing Corp2007-08-30
EUFLEXXA (P010029/S004)Ferring Pharmaceuticals, Inc.2007-08-23
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S004)Ceramtec GmbH2007-08-17
EXOGEN 4000+BONE HEALING SYSTEM (P900009/S027)Bioventus, LLC2007-08-16
EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S028)Bioventus, LLC2007-08-16
LCS TOTAL KNEE SYSTEM-RPF FEMORAL COMPONENT LINE EXTENSION (P830055/S099)Depuy, Inc.2007-08-14
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S003)Smith & Nephew, Inc.2007-08-14
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S005)Biomet Manufacturing Corp2007-08-03
PRESTIGE CERVICAL DISC SYSTEM (P060018)Medtronic Sofamor Danek, Inc.2007-07-16
EUFLEXXA 1% SODIUM HYALURONATE (P010029/S006)Ferring Pharmaceuticals, Inc.2007-07-11
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S015)Biomet Manufacturing Corp2007-07-05
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039)Exactech, Inc.2007-07-05
CORMET HIP RESURFACING SYSTEM (P050016)Corin USA2007-07-03
INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE (P000058/S021)Medtronic Sofamor Danek USA, Inc.2007-07-03
INFUSE BONE GRAFT (P000054/S010)Medtronic Sofamor Danek USA, Inc.2007-07-03
SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S023)Djo, LLC2007-06-28
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S005)Smith & Nephew, Inc.2007-06-27
SPF PLUS 60/W AND SPF-PLUS 60/M (P850035/S031)Ahp Eos Buyer, Inc.2007-06-21
LCS TOTAL KNEE SYSTEM (P830055/S097)Depuy, Inc.2007-06-15
EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S025)Bioventus, LLC2007-06-11
TRILOGY AB ACETABULAR SYSTEM (P040048/S002)Zimmer, Inc.2007-06-08
EMS SWISS DOLORCLAST (P050004)Electro Medical Systems (Ems Sa)2007-05-08
REFLECTION CERAMIC HIP SYSTEM (P030022/S004)Smith & Nephew, Inc.2007-05-04
OSTEONICS ABC / TRIDENT SYSTEMS (P000013/S008)Howmedica Osteonics Corp.2007-04-26
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S003)Biomet Manufacturing Corp2007-04-20
INFUSE BONE GRAFT (P000054/S008)Medtronic Sofamor Danek USA, Inc.2007-03-23
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE (P000058/S019)Medtronic Sofamor Danek USA, Inc.2007-03-23
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S013)Anika Therapeutics, Inc.2007-03-15
MBT TIBIAL TRAY (P830055/S098)Depuy, Inc.2007-03-13
SUPARTZ (P980044/S006)Seikagaku Corp.2007-03-07
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S002)Smith & Nephew, Inc.2007-02-23
SUPARTZ (P980044/S005)Seikagaku Corp.2007-02-13
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S004)Medtronic Sofamor Danek, Inc.2006-12-29
TRILOGY AB ACETABULAR SYSTEM (P040048/S001)Zimmer, Inc.2006-12-28
CHARITE ARTIFICIAL DISC (P040006/S003)Depuy Spine, Inc.2006-12-15
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S011)Biomet Manufacturing Corp2006-12-15
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S001)Medtronic Sofamor Danek, Inc.2006-12-08
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S012)Anika Therapeutics, Inc.2006-11-08
EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S024)Bioventus, LLC2006-11-01
X-STOP IPD SYSTEM (P040001/S003)Medtronic Sofamor Danek, Inc.2006-10-19
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S008)DePuy Orthopaedics, Inc.2006-10-18
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S001)Smith & Nephew, Inc.2006-10-13
OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR (P910066/S022)Djo, LLC2006-10-13
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S006)DePuy Orthopaedics, Inc.2006-09-20
SUPARTZ (P980044/S004)Seikagaku Corp.2006-08-25
PRODISC -L TOTAL DISC REPLACEMENT DEVICE (P050010)Centinel Spine, LLC2006-08-14
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S010)Anika Therapeutics, Inc.2006-08-09
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S002)Medtronic Sofamor Danek, Inc.2006-08-08
ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM (P850022/S016)Ahp Eos Buyer, Inc.2006-07-27
AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028/S008)Medtronic Sofamor Danek USA, Inc.2006-07-25
OXFORD MENISCAL UNICOMPARTMENTAL KNEE (P010014/S009)Biomet Manufacturing Corp2006-07-18
ASCENSION MCP (P000057/S003)Smith & Nephew, Inc.2006-07-17
EXOGEN 2000+ BONE HEALING SYSTEM (P900009/S023)Bioventus, LLC2006-06-30
TRILOGY AB ACETABULAR SYSTEM (P040048)Zimmer, Inc.2006-06-28
EXOGEN 4000+ BONE HEALING SYSTEM (P900009/S022)Bioventus, LLC2006-06-26
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S002)Microport Orthopedics, Inc.2006-06-23
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S002)Smith & Nephew, Inc.2006-06-16
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S007)DePuy Orthopaedics, Inc.2006-05-26
STELKAST SURPASS ACETABULAR SYSTEM (P040051)Stelkast Company2006-05-12
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033)Smith & Nephew, Inc.2006-05-09
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S004)Biomet Manufacturing Corp2006-03-31
CHARITE ARTIFICIAL DISC (P040006/S002)Depuy Spine, Inc.2006-03-29
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S001)Biomet Manufacturing Corp2006-03-23
LCS TOTAL KNEE SYSTEM (P830055/S096)Depuy, Inc.2006-03-22
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S008)Biomet Manufacturing Corp2006-03-15
TRIDENT CERAMIC ON CERAMIC ACETABULAR SYSTEM (P000013/S006)Howmedica Osteonics Corp.2006-03-14
NUXFLEXXA (SODIUM HYALURONATE) (P010029/S001)Ferring Pharmaceuticals, Inc.2006-02-27
LCS TOTAL KNEE SYSTEM (P830055/S095)Depuy, Inc.2006-02-22
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S001)Microport Orthopedics, Inc.2006-02-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S001)DePuy Orthopaedics, Inc.2006-02-01
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S008)Anika Therapeutics, Inc.2006-01-30
SUPARTZ (P980044/S003)Seikagaku Corp.2006-01-20
LCS TOTAL KNEE SYSTEM (P830055/S094)Depuy, Inc.2006-01-20
DURALOC OPTION CERAMIC-ON-CERAMIC HIP SYSTEM (P040023/S003)DePuy Orthopaedics, Inc.2005-12-22
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16
LCS UNI KNEE SYSTEM (P910016/S015)Depuy, Inc.2005-12-12
DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S002)DePuy Orthopaedics, Inc.2005-12-12
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S002)Ceramtec GmbH2005-12-12
LCS TOTAL KNEE SYSTEM (P830055/S093)Depuy, Inc.2005-12-12
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001)Medtronic Sofamor Danek, Inc.2005-11-21
LCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM (P830055/S092)Depuy, Inc.2005-11-17
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S001)Smith & Nephew, Inc.2005-11-17
EUFLEXXA (P010029/S002)Ferring Pharmaceuticals, Inc.2005-10-20
LCS TOTAL KNEE SYSTEM (P830055/S090)Depuy, Inc.2005-09-26
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