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Orthopedic

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

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RecordFirmDate
INFUSE BONE GRAFT (P000054/S033)Medtronic Sofamor Danek USA, Inc.2012-07-17
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S048)Medtronic Sofamor Danek USA, Inc.2012-07-17
PRODISC-L TOTAL DISC REPLACEMENT (P050010/S012)Centinel Spine, LLC2012-07-10
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S021)Smith & Nephew, Inc.2012-06-28
SYNVISC AND SYNVISC-ONE (P940015/S026)Sanofi Genzyme Corp.2012-06-22
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S004)DePuy Orthopaedics, Inc.2012-06-15
DUROLOC OPTION CERAMIC HIP SYSTEM (P040023/S022)DePuy Orthopaedics, Inc.2012-06-15
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S021)DePuy Orthopaedics, Inc.2012-06-15
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S006)DePuy Orthopaedics, Inc.2012-06-15
ULTRASOUND BONE HEALING SYSTEM (P900009/S033)Bioventus, LLC2012-06-06
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S015)Ferring Pharmaceuticals, Inc.2012-05-04
SUPARTZ (P980044/S013)Seikagaku Corp.2012-05-04
GEL-ONE (P080020/S001)Seikagaku Corp.2012-05-04
SYNVISC & SYNVISC-ONE (P940015/S025)Sanofi Genzyme Corp.2012-05-03
EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S007)Exactech, Inc.2012-04-27
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S020)DePuy Orthopaedics, Inc.2012-04-26
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S005)DePuy Orthopaedics, Inc.2012-04-26
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S009)Exactech, Inc.2012-04-26
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S003)DePuy Orthopaedics, Inc.2012-04-26
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S009)Ceramtec GmbH2012-04-19
DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S002)DePuy Orthopaedics, Inc.2012-04-17
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S014)Ferring Pharmaceuticals, Inc.2012-03-30
LCS TOTAL KNEE SYSTEM (P830055/S126)Depuy, Inc.2012-03-30
LCS TOTAL KNEE SYSTEM (P830055/S124)Depuy, Inc.2012-03-16
INFUSE BONE GRAFT (P000054/S029)Medtronic Sofamor Danek USA, Inc.2012-03-15
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S042)Medtronic Sofamor Danek USA, Inc.2012-03-15
BRYAN CERVICAL DISC (P060023/S001)Companion Spine France Sas2012-03-09
DEPUY DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S018)DePuy Orthopaedics, Inc.2012-03-08
SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) (P850035/S034)Ahp Eos Buyer, Inc.2012-02-27
LCS TOTAL KNEE SYSTEM (P830055/S125)Depuy, Inc.2012-02-21
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S010)Ceramtec GmbH2012-02-14
NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S016)Zimmer, Inc.2012-02-10
TRILOGY AB ACETABULAR SYSTEM (P040048/S016)Zimmer, Inc.2012-02-10
LCS TOTAL KNEE SYSTEM (P830055/S121)Depuy, Inc.2012-02-09
LCS TOTAL KNEE SYSTEM (P830055/S122)Depuy, Inc.2012-02-06
OXFORD PARTIAL KNEE SYSTEM (P010014/S033)Biomet Manufacturing Corp2012-02-03
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S013)Ferring Pharmaceuticals, Inc.2012-01-27
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S020)Smith & Nephew, Inc.2012-01-20
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S048)Ahp Eos Buyer, Inc.2012-01-20
TRIDENT SYSTEMS (P000013/S010)Howmedica Osteonics Corp.2012-01-18
LCS TOTAL KNEE SYSTEM (P830055/S119)Depuy, Inc.2012-01-06
SYNVISC & SYNVISC-ONE (P940015/S024)Sanofi Genzyme Corp.2012-01-05
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S014)Anika Therapeutics, Inc.2011-12-30
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S045)Medtronic Sofamor Danek USA, Inc.2011-12-23
NEXGEN COMPLETE KNEE SOLUTION (P060037/S015)Zimmer, Inc.2011-12-23
PRODISC -C TOTAL DISC REPLACEMENT (P070001/S010)Centinel Spine, LLC2011-12-22
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S014)Zimmer, Inc.2011-12-21
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S019)DePuy Orthopaedics, Inc.2011-12-20
LCS TOTAL KNEE SYSTEM (P830055/S106)Depuy, Inc.2011-11-23
CORMET HIP RESURFACING SYSTEM (P050016/S008)Corin USA2011-11-10
TRILOGY AB ACETABULAR SYSTEM (P040048/S015)Zimmer, Inc.2011-11-04
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S001)DePuy Orthopaedics, Inc.2011-11-04
CERVICAL-STIM (P030034/S006)Orthofix, Inc.2011-11-02
PHYSIO-STIM & SPINAL-STIM (P850007/S032)Orthofix, Inc.2011-11-02
BIRMINGHAM HIP RESURFACING SYSTEM (BHR) (P040033/S017)Smith & Nephew, Inc.2011-10-14
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S017)Smith & Nephew, Inc.2011-10-14
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S008)Ferring Pharmaceuticals, Inc.2011-10-11
SYNVISC AND SYNVISC-ONE (P940015/S022)Sanofi Genzyme Corp.2011-10-07
SYNVISC & SYNVISC-ONE (HYLAN G-F 20) (P940015/S023)Sanofi Genzyme Corp.2011-10-07
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S046)Medtronic Sofamor Danek USA, Inc.2011-10-05
PRODISC -L TOTAL DISC REPLACEMENT (P050010/S009)Centinel Spine, LLC2011-10-04
PRODISC - L TOTAL DISC REPLACEMENT (P050010/S011)Centinel Spine, LLC2011-09-16
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S003)DePuy Orthopaedics, Inc.2011-09-16
BIO OSTEOGEN SYSTEM (P790002/S027)Ahp Eos Buyer, Inc.2011-09-07
ASCENSION ORTHOPEDICS MCP (P000057/S006)Smith & Nephew, Inc.2011-08-26
PRODISC -C TOTAL DISC REPLACEMENT (P070001/S011)Centinel Spine, LLC2011-08-18
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S019)Smith & Nephew, Inc.2011-08-12
BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S018)Ahp Eos Buyer, Inc.2011-08-11
CONSERVE PLUS TOTAL RESURFACING SYSTEM (P030042/S004)Microport Orthopedics, Inc.2011-08-08
OXFORD UNICOMPARTMENTAL KNEE SYSTEM (P010014/S014)Biomet Manufacturing Corp2011-08-05
OXFORD PARTIAL KNEE (P010014/S031)Biomet Manufacturing Corp2011-07-29
AMSONIC 9 STAGE WASH SYSTEM (P010014/S032)Biomet Manufacturing Corp2011-07-28
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S021)Smith & Nephew, Inc.2011-07-27
SYNVISC AND SYNVISC-ONE (P940015/S021)Sanofi Genzyme Corp.2011-07-07
LCS TOTAL KNEE SYSTEM (P830055/S118)Depuy, Inc.2011-07-01
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002)DePuy Orthopaedics, Inc.2011-06-13
DEPUY CERMAX CERAMIC TOTAL HIP SYSTEM (P070026/S001)DePuy Orthopaedics, Inc.2011-06-07
TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT (P040048/S014)Zimmer, Inc.2011-06-02
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S018)Smith & Nephew, Inc.2011-05-26
BIOMET EBI BONE HEALING SYSTEM (P790002/S026)Ahp Eos Buyer, Inc.2011-05-19
ORTHOGEN/OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S047)Ahp Eos Buyer, Inc.2011-05-06
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019)Medtronic Sofamor Danek, Inc.2011-05-04
OXFORD PARTIAL KNEE SYSTEM (P010014/S029)Biomet Manufacturing Corp2011-05-03
STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002)Stelkast Company2011-04-22
INFUSE BONE GRAFT (P000054/S027)Medtronic Sofamor Danek USA, Inc.2011-04-04
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S040)Medtronic Sofamor Danek USA, Inc.2011-04-04
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S012)Ferring Pharmaceuticals, Inc.2011-04-01
BIRMINGHAM HIP RESURFACING SYSTEM (BHR) (P040033/S019)Smith & Nephew, Inc.2011-04-01
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S005)Exactech, Inc.2011-03-31
OXFORD PARTIAL KNEE SYSTEM (P010014/S030)Biomet Manufacturing Corp2011-03-24
PRESTIGE CERVICAL DISC (P060018/S002)Medtronic Sofamor Danek, Inc.2011-03-24
GEL-ONE (P080020)Seikagaku Corp.2011-03-22
ORTHOVISC (P030019/S017)Anika Therapeutics, Inc.2011-03-18
SYNVISC & SYNVISC-ONE (P940015/S020)Sanofi Genzyme Corp.2011-03-18
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S020)Smith & Nephew, Inc.2011-03-16
LCS COMPLETE TOTAL KNEE SYSTEM (P830055/S115)Depuy, Inc.2011-03-11
SPINAL-STIM SPINAL FUSION SYSTEM (P850007/S031)Orthofix, Inc.2011-03-11
CERVICAL-STIM CERVICAL FUSION SYSTEM (P030034/S005)Orthofix, Inc.2011-03-11
PRODISC-L TOTAL DISC REPLACEMENT (P050010/S010)Centinel Spine, LLC2011-03-03
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S008)Ceramtec GmbH2011-02-25
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