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Orthopedic

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

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RecordFirmDate
LCS TOTAL KNEE SYSTEM (P830055/S107)Depuy, Inc.2011-02-22
PRODISC -C TOTAL DISC REPLACEMENT (P070001/S009)Centinel Spine, LLC2011-02-16
PRODISC -L TOTAL DISC REPLACEMENT (P050010/S008)Centinel Spine, LLC2011-02-16
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005)Depuy Spine, Inc.2011-02-08
FLEX MOBILE BEARING KNEE (P060037/S012)Zimmer, Inc.2011-01-31
INFUSE BONE GRAFT (P000054/S026)Medtronic Sofamor Danek USA, Inc.2011-01-26
INFUSE BONE GRAFT (P000058/S039)Medtronic Sofamor Danek USA, Inc.2011-01-26
PRODISC-L TOTAL DISC REPLACEMENT (P050010/S007)Centinel Spine, LLC2011-01-14
PRODISC-C TOTAL DISC REPLACEMENT (P070001/S004)Centinel Spine, LLC2011-01-14
CORMET HIP RESURFACING SYSTEM (P050016/S007)Corin USA2011-01-13
PHYSIO-STIM/SPINAL-STIM (P850007/S030)Orthofix, Inc.2011-01-12
CERVICAL-STIM (P030034/S004)Orthofix, Inc.2011-01-12
LCS TOTAL KNEE SYSTEM (P830055/S117)Depuy, Inc.2011-01-10
OXFORD PARTIAL KNEE SYSTEM (P010014/S028)Biomet Manufacturing Corp2011-01-07
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (P050050/S002)Djo Global2010-12-27
CERAMAX CERAMIC HIP SYSTEM (P070026)DePuy Orthopaedics, Inc.2010-12-23
LCS TOTAL KNEE SYSTEM (P830055/S116)Depuy, Inc.2010-12-17
DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S004)DePuy Orthopaedics, Inc.2010-12-13
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S004)Exactech, Inc.2010-12-09
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S015)Smith & Nephew, Inc.2010-12-07
INFUSE BONE GRAFT (P000054/S025)Medtronic Sofamor Danek USA, Inc.2010-12-07
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S038)Medtronic Sofamor Danek USA, Inc.2010-12-07
SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20) (P940015/S018)Sanofi Genzyme Corp.2010-11-24
PRODISC C TOTAL DISC REPLACEMENT (P070001/S005)Centinel Spine, LLC2010-11-19
ZIMMER NEXGEN LPS-FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEMS (P060037/S009)Zimmer, Inc.2010-11-03
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S010)Ferring Pharmaceuticals, Inc.2010-10-25
NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S013)Zimmer, Inc.2010-10-20
SUPARTZ (P980044/S012)Seikagaku Corp.2010-10-19
ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S017)Ahp Eos Buyer, Inc.2010-10-15
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S016)Smith & Nephew, Inc.2010-10-13
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (P050050/S001)Djo Global2010-10-08
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S007)Ceramtec GmbH2010-09-15
SYNVISC & SYNVISC-ONE (P940015/S019)Sanofi Genzyme Corp.2010-09-15
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S006)Ceramtec GmbH2010-09-15
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S016)DePuy Orthopaedics, Inc.2010-09-02
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S027)Biomet Manufacturing Corp2010-08-31
REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S016)Smith & Nephew, Inc.2010-07-30
CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042/S002)Microport Orthopedics, Inc.2010-07-16
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S015)Anika Therapeutics, Inc.2010-07-15
CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S005)Ceramtec GmbH2010-07-06
PRODISC-C TOTAL DISC REPLACEMENT (P070001/S008)Centinel Spine, LLC2010-07-02
PRODISC-C TOTAL DISC REPLACEMENT (P070001/S007)Centinel Spine, LLC2010-07-02
PRO-DISC C TOTAL DISC REPLACEMENT (P070001/S006)Centinel Spine, LLC2010-06-25
CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL (P030042/S003)Microport Orthopedics, Inc.2010-06-21
REFLECTION CERAMIC ACETABULAR HIP (RCHS) (P030022/S014)Smith & Nephew, Inc.2010-06-11
TRILOGY AB ACETABULAR SYSTEM (P040048/S009)Zimmer, Inc.2010-06-04
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S015)DePuy Orthopaedics, Inc.2010-06-04
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S017)Medtronic Sofamor Danek, Inc.2010-06-02
PRODISC L TOTAL REPLACEMENT (P050010/S005)Centinel Spine, LLC2010-05-26
PRODISC L TOTAL DISC REPLACEMENT (P050010/S006)Centinel Spine, LLC2010-05-26
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S036)Medtronic Sofamor Danek USA, Inc.2010-05-17
INFUSE BONE GRAFT (P000054/S024)Medtronic Sofamor Danek USA, Inc.2010-05-17
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S016)Medtronic Sofamor Danek, Inc.2010-04-30
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S014)DePuy Orthopaedics, Inc.2010-04-20
OXFORD MENSICAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S026)Biomet Manufacturing Corp2010-03-29
HYALGAN (P950027/S012)Fidia Farmaceutici S.P.A.2010-03-28
EXOGEN 4000+ (P900009/S032)Bioventus, LLC2010-03-26
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (OXFORD PARTIAL KNEE SYSTEM) (P010014/S024)Biomet Manufacturing Corp2010-03-17
SYNVISC-ONE (HYLAN G-F 20) (P940015/S017)Sanofi Genzyme Corp.2010-03-12
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S015)Smith & Nephew, Inc.2010-03-09
LCS TOTAL KNEE SYSTEM (P830055/S114)Depuy, Inc.2010-02-04
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S012)Medtronic Sofamor Danek, Inc.2010-01-28
INFUSE BONE GRAFT/LT- CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S030)Medtronic Sofamor Danek USA, Inc.2010-01-20
INFUSE BONE GRAFT (P000054/S019)Medtronic Sofamor Danek USA, Inc.2010-01-20
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S034)Medtronic Sofamor Danek USA, Inc.2010-01-14
INFUSE BONE GRAFT (P000054/S023)Medtronic Sofamor Danek USA, Inc.2010-01-14
TRILOGY AB ACETABULAR SYSTEM (P040048/S011)Zimmer, Inc.2010-01-11
CORMET HIP RESURFACING SYSTEM (P050016/S006)Corin USA2009-12-31
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S013)Smith & Nephew, Inc.2009-12-31
EUFLEXXA ( 1% SODIUM HYALURONATE) (P010029/S011)Ferring Pharmaceuticals, Inc.2009-12-22
LCS TOTAL KNEE SYSTEM (P830055/S113)Depuy, Inc.2009-12-22
TRILOGY AB ACETABULAR SYSTEM (P040048/S012)Zimmer, Inc.2009-12-22
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S009)Ferring Pharmaceuticals, Inc.2009-12-16
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S014)Smith & Nephew, Inc.2009-12-11
LCS TOTAL KNEE SYSTEM ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS (P830055/S112)Depuy, Inc.2009-12-08
TRILOGY AB ACETABULAR SYSTEM (P040048/S010)Zimmer, Inc.2009-12-08
ASCENSION MCP (P000057/S005)Smith & Nephew, Inc.2009-12-04
CORMET HIP RESURFACING SYSTEM (P050016/S005)Corin USA2009-12-03
LCS TOTAL KNEE SYSTEM (P830055/S108)Depuy, Inc.2009-11-09
CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM (P030042)Microport Orthopedics, Inc.2009-11-03
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S015)Medtronic Sofamor Danek, Inc.2009-10-21
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S033)Medtronic Sofamor Danek USA, Inc.2009-10-21
INFUSE BONE GRAFT (P000054/S022)Medtronic Sofamor Danek USA, Inc.2009-10-21
BIRMINGHAM HIP RESURFACING SYSTEM, REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P040033/S012)Smith & Nephew, Inc.2009-10-07
REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S012)Smith & Nephew, Inc.2009-10-07
EXOGEN BONE HEALING SYSTEM (P900009/S031)Bioventus, LLC2009-10-02
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S003)Exactech, Inc.2009-09-30
SUPARTZ (P980044/S010)Seikagaku Corp.2009-09-25
LCS TOTAL KNEE SYSTEM (P830055/S111)Depuy, Inc.2009-09-16
REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM (P030022/S013)Smith & Nephew, Inc.2009-09-11
CERVICAL-STIM (P030034/S003)Orthofix, Inc.2009-09-11
PHYSIO-STIM AND SPINAL STIM (P850007/S029)Orthofix, Inc.2009-09-11
TRILOGY AB ACETABULAR SYSTEM (P040048/S008)Zimmer, Inc.2009-08-27
SYNVISC (P940015/S015)Sanofi Genzyme Corp.2009-08-20
PHYSIO-STIM & SPINAL-STIM (P850007/S028)Orthofix, Inc.2009-07-10
CERVICAL STIM (P030034/S002)Orthofix, Inc.2009-07-10
SUPARTZ JOINT FLUID THERAPY (P980044/S009)Seikagaku Corp.2009-07-08
SUPARTZ (P980044/S007)Seikagaku Corp.2009-07-07
NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE (P060037/S011)Zimmer, Inc.2009-07-06
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