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Orthopedic

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

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RecordFirmDate
DEPUY CERAMAX TOTAL HIP SYSTEM (P070026/S012)DePuy Orthopaedics, Inc.2013-08-06
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S009)DePuy Orthopaedics, Inc.2013-08-06
REFLECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S024)Smith & Nephew, Inc.2013-08-06
REFLECTION CERAMIC HIP SYSTEM (P030022/S023)Smith & Nephew, Inc.2013-08-01
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S049)Medtronic Sofamor Danek USA, Inc.2013-08-01
INFUSE BONE GRAFT (P000054/S034)Medtronic Sofamor Danek USA, Inc.2013-08-01
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S023)Zimmer, Inc.2013-07-31
OXFORD PARTIAL KNEE (P010014/S044)Biomet Manufacturing Corp2013-07-30
SUPARTZ (P980044/S016)Seikagaku Corp.2013-07-25
TOTAL KNEE SYSTEM (P830055/S135)Depuy, Inc.2013-07-17
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S008)DePuy Orthopaedics, Inc.2013-07-17
SUPARTZ (P980044/S015)Seikagaku Corp.2013-07-12
PRESTIGE CERVICAL DISC (P060018/S003)Medtronic Sofamor Danek, Inc.2013-07-12
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S014)DePuy Orthopaedics, Inc.2013-07-02
SYNVISC AND SYNVISC-ONE (P940015/S027)Sanofi Genzyme Corp.2013-06-28
OXFORD PARTIAL KNEE SYSTEM (P010014/S043)Biomet Manufacturing Corp2013-06-25
ZIMMER NEXT GEN LPS -FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S022)Zimmer, Inc.2013-06-21
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S006)Microport Orthopedics, Inc.2013-06-20
LCS TOTAL KNEE SYSTEM (P830055/S134)Depuy, Inc.2013-06-11
EUFLEXXA (P010029/S017)Ferring Pharmaceuticals, Inc.2013-06-04
INFUSE BONE GRAFT (P000054/S039)Medtronic Sofamor Danek USA, Inc.2013-05-31
SPF IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S035)Ahp Eos Buyer, Inc.2013-05-28
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S049)Ahp Eos Buyer, Inc.2013-05-28
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S013)DePuy Orthopaedics, Inc.2013-05-07
NUVASIVE PCM CERVICAL DISC (P100012/S004)Nuvasive, Inc.2013-05-03
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) (P050050/S004)Djo Global2013-05-01
OXFORD PARTIAL KNEE SYSTEM (P010014/S042)Biomet Manufacturing Corp2013-04-25
COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S001)Companion Spine France2013-04-23
COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S002)Companion Spine France2013-04-23
LCS TOTAL KNEE SYSTEM (P830055/S133)Depuy, Inc.2013-04-12
NUVASIVE'S PCM CERVICAL DISC (P100012/S003)Nuvasive, Inc.2013-04-10
LCS TOTAL KNEE SYSTEM (P830055/S131)Depuy, Inc.2013-04-10
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S004)DePuy Orthopaedics, Inc.2013-04-02
PCM CERVICAL DISC (P100012/S002)Nuvasive, Inc.2013-03-29
NEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES (P060037/S020)Zimmer, Inc.2013-03-28
INFUSE BONE GRAFT (P000054/S038)Medtronic Sofamor Danek USA, Inc.2013-03-27
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S053)Medtronic Sofamor Danek USA, Inc.2013-03-27
CORMET HIP RESURFACING SYSTEM (P050016/S009)Corin USA2013-03-22
LCS TOTAL KNEE SYSTEM (P830055/S130)Depuy, Inc.2013-03-15
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001)Globus Medical, Inc.2013-03-15
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S016)Ferring Pharmaceuticals, Inc.2013-03-13
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S019)Zimmer, Inc.2013-02-20
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S011)DePuy Orthopaedics, Inc.2013-02-19
OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS (P010014/S041)Biomet Manufacturing Corp2013-02-14
INFUSE BONE GRAFT (P000054/S037)Medtronic Sofamor Danek USA, Inc.2013-02-13
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S052)Medtronic Sofamor Danek USA, Inc.2013-02-13
BIOMET EBI BONE HEALING SYSTEM (P790002/S028)Ahp Eos Buyer, Inc.2013-02-08
INFUSE BONE GRAFT (P000054/S036)Medtronic Sofamor Danek USA, Inc.2013-02-07
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015)Exactech, Inc.2013-02-07
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S051)Medtronic Sofamor Danek USA, Inc.2013-02-07
NUVASIVE'S PCM CERVICAL DISC (P100012/S001)Nuvasive, Inc.2013-02-06
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) (P050050/S005)Djo Global2013-01-24
BRYAN CERVICAL DISC (P060023/S004)Companion Spine France Sas2013-01-11
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S039)Biomet Manufacturing Corp2013-01-04
BIOMET BHS-MINI (P790002/S029)Ahp Eos Buyer, Inc.2012-12-31
OXFORD PARTIAL KNEE SYSTEM (P010014/S040)Biomet Manufacturing Corp2012-12-21
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S007)DePuy Orthopaedics, Inc.2012-12-21
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014)Exactech, Inc.2012-12-05
BRYAN CERVICAL DISC (P060023/S003)Companion Spine France Sas2012-11-30
GEL-ONE (P080020/S004)Seikagaku Corp.2012-11-30
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S009)DePuy Orthopaedics, Inc.2012-11-21
DEPUY CREAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S010)DePuy Orthopaedics, Inc.2012-11-20
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S025)DePuy Orthopaedics, Inc.2012-11-20
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S006)DePuy Orthopaedics, Inc.2012-11-20
LCS TOTAL KNEE SYSTEM (P830055/S127)Depuy, Inc.2012-11-19
LCS TOTAL KNEE SYSTEM (P830055/S128)Depuy, Inc.2012-11-19
TRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM (P000013/S011)Howmedica Osteonics Corp.2012-11-02
GEL-ONE (P080020/S003)Seikagaku Corp.2012-11-01
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S013)Exactech, Inc.2012-11-01
NUVASIVE PCM CERVICAL DISC SYSTEM (P100012)Nuvasive, Inc.2012-10-26
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S050)Medtronic Sofamor Danek USA, Inc.2012-10-25
TRILOGY AB ACETABULAR SYSTEM (P040048/S017)Zimmer, Inc.2012-10-25
NEXGEN LPS/LPS FLEX MOBILE KNEE (P060037/S017)Zimmer, Inc.2012-10-25
INFUSE BONE GRAFT (P000054/S035)Medtronic Sofamor Danek USA, Inc.2012-10-25
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S044)Medtronic Sofamor Danek USA, Inc.2012-10-17
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S012)Exactech, Inc.2012-10-17
COFLEX® INTERLAMINAR TECHNOLOGY (P110008)Companion Spine France2012-10-17
INFUSE BONE GRAFT (P000054/S031)Medtronic Sofamor Danek USA, Inc.2012-10-17
GEL-ONE (P080020/S002)Seikagaku Corp.2012-10-10
SECURE-C ARTIFICIAL CERVICAL DISC (P100003)Globus Medical, Inc.2012-09-28
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S011)Exactech, Inc.2012-09-27
SUPARTZ (P980044/S014)Seikagaku Corp.2012-09-18
BRYAN CERVICAL DISC (P060023/S002)Companion Spine France Sas2012-09-13
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S018)Smith & Nephew, Inc.2012-09-11
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S022)Smith & Nephew, Inc.2012-09-06
PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002/S005)DePuy Orthopaedics, Inc.2012-09-06
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S007)DePuy Orthopaedics, Inc.2012-09-06
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S024)DePuy Orthopaedics, Inc.2012-09-06
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S010)Exactech, Inc.2012-08-24
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S008)Exactech, Inc.2012-08-17
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S037)Biomet Manufacturing Corp2012-08-15
OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S026)Djo, LLC2012-08-10
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES (P060037/S018)Zimmer, Inc.2012-08-10
INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S041)Medtronic Sofamor Danek USA, Inc.2012-08-03
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S043)Medtronic Sofamor Danek USA, Inc.2012-08-03
INFUSE BONE GRAFT (P000054/S028)Medtronic Sofamor Danek USA, Inc.2012-08-03
INFUSE BONE GRAFT (P000054/S030)Medtronic Sofamor Danek USA, Inc.2012-08-03
OXFORD PATIAL KNEE SYSTEM (P010014/S036)Biomet Manufacturing Corp2012-08-02
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020)Medtronic Sofamor Danek, Inc.2012-07-25
OXFORD PARTIAL KNEE SYSTEM (P010014/S035)Biomet Manufacturing Corp2012-07-19
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