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Orthopedic

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

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RecordFirmDate
EUFLEXXA 1% SODIUM HYALURONATE (P010029/S007)Ferring Pharmaceuticals, Inc.2009-07-01
ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS (P060037/S010)Zimmer, Inc.2009-06-19
BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S011)Smith & Nephew, Inc.2009-06-09
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) (P050050)Djo Global2009-05-27
LCS TOTAL KNEE SYSTEM (P830055/S109)Depuy, Inc.2009-05-18
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S032)Medtronic Sofamor Danek USA, Inc.2009-05-13
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000054/S021)Medtronic Sofamor Danek USA, Inc.2009-05-13
BRYAN CERVICAL DISC PROSTHESIS (P060023)Companion Spine France Sas2009-05-12
STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001)Stelkast Company2009-05-08
NEXGEN LPS-FLEX/LPS-MOBILE BEARING KNEE (P060037/S008)Zimmer, Inc.2009-05-08
OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S009)Howmedica Osteonics Corp.2009-05-07
LCS TOTAL KNEE SYSTEM (P830055/S110)Depuy, Inc.2009-05-06
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S014)Medtronic Sofamor Danek, Inc.2009-04-16
SYNVISC (P940015/S013)Sanofi Genzyme Corp.2009-04-10
NEXGEN COMPLETE KNEE SOLUTION (P060037/S005)Zimmer, Inc.2009-03-26
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
EXOGEN 4000+ BONE HEALING SYSTEM (P900009/S030)Bioventus, LLC2009-03-13
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S013)Medtronic Sofamor Danek, Inc.2009-03-11
SYNVISC & SYNVISC-ONE (HYLAN G-F 20) (P940015/S014)Sanofi Genzyme Corp.2009-03-11
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S010)Smith & Nephew, Inc.2009-03-06
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S011)DePuy Orthopaedics, Inc.2009-03-04
SYNVISC-ONE (P940015/S012)Sanofi Genzyme Corp.2009-02-26
INFUSE BONE GRAFT (P000054/S020)Medtronic Sofamor Danek USA, Inc.2009-02-20
INFUSE BONE GRAFT/LT-CAGE LUMBER TAPERED FUSION DEVICE (P000058/S031)Medtronic Sofamor Danek USA, Inc.2009-02-20
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S008)Smith & Nephew, Inc.2009-02-18
ZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS (P060037/S006)Zimmer, Inc.2009-02-13
KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM (N980003/S007)Djo Surgical2009-02-13
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S010)Smith & Nephew, Inc.2009-02-13
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S007)Zimmer, Inc.2009-01-23
X-STOP IPD SYSTEM (P040001/S011)Medtronic Sofamor Danek, Inc.2009-01-14
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S008)Smith & Nephew, Inc.2009-01-12
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S012)DePuy Orthopaedics, Inc.2008-12-30
SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S025)Djo, LLC2008-12-24
EXOGEN BONE HEALING SYSTEM 2000 ,3000 (P900009/S021)Bioventus, LLC2008-12-19
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S013)DePuy Orthopaedics, Inc.2008-12-19
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S011)Smith & Nephew, Inc.2008-12-18
BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S009)Smith & Nephew, Inc.2008-12-18
EXOGEN 4000+BONE HEALING SYSTEM (P900009/S029)Bioventus, LLC2008-12-18
NEXGEN LEGACY KNEE ¿ POSTERIOR STABILIZED (LPS), LPS-FLEX MOBILE BEARING KNEE (P060037/S003)Zimmer, Inc.2008-12-16
INFUSE BONE GRAFT (P000054/S017)Medtronic Sofamor Danek USA, Inc.2008-12-04
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S028)Medtronic Sofamor Danek USA, Inc.2008-12-04
INFUSE BONE GRAFT / LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S029)Medtronic Sofamor Danek USA, Inc.2008-11-24
INFUSE BONE GRAFT (P000054/S018)Medtronic Sofamor Danek USA, Inc.2008-11-24
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S022)Biomet Manufacturing Corp2008-11-21
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S002)Exactech, Inc.2008-11-19
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S006)Smith & Nephew, Inc.2008-11-13
NOVATION CERAMIC AHS (P050039/S001)Exactech, Inc.2008-11-13
LPS-FLEX MOBILE (P060037/S004)Zimmer, Inc.2008-11-06
CORMET HIP RESUFACING SYSTEM (P050016/S004)Corin USA2008-11-04
PRODISC L TOTAL DISC REPLACEMENT (P050010/S002)Centinel Spine, LLC2008-10-14
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S003)Smith & Nephew, Inc.2008-10-14
LCS TOTAL KNEE SYSTEM (P830055/S104)Depuy, Inc.2008-10-10
OXFORD MENISCAL UNICOMPARTMENTAL KNEE (OXFORD PARTIAL KNEE SYSTEM) (P010014/S020)Biomet Manufacturing Corp2008-09-18
SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) (P850035/S033)Ahp Eos Buyer, Inc.2008-09-18
SUPARTZ (P980044/S008)Seikagaku Corp.2008-08-29
PRODISC L TOTAL DISC REPLACEMENT (P050010/S003)Centinel Spine, LLC2008-08-26
INFUSE BONE GRAFT (P000054/S015)Medtronic Sofamor Danek USA, Inc.2008-08-15
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S026)Medtronic Sofamor Danek USA, Inc.2008-08-15
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S032)Ahp Eos Buyer, Inc.2008-08-15
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S045)Ahp Eos Buyer, Inc.2008-08-15
OXFORD PARTIAL KNEE (P010014/S021)Biomet Manufacturing Corp2008-08-15
PRODISC C TOTAL DISC REPLACEMENT (P070001/S002)Centinel Spine, LLC2008-08-11
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S005)Smith & Nephew, Inc.2008-07-25
TRILOGY AB ACETABULAR SYSTEM (P040048/S004)Zimmer, Inc.2008-07-25
LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS (P830055/S103)Depuy, Inc.2008-07-16
X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S009)Medtronic Sofamor Danek, Inc.2008-07-09
CORMET HIP RESURFACING SYSTEM (P050016/S003)Corin USA2008-07-07
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S003)Ceramtec GmbH2008-07-03
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S009)Smith & Nephew, Inc.2008-07-02
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S007)Smith & Nephew, Inc.2008-06-20
SYNVISC HYLAN G-F 20 (P940015/S011)Sanofi Genzyme Corp.2008-06-09
HYALGAN (P950027/S011)Fidia Farmaceutici S.P.A.2008-05-23
TRILOGY AB ACETABULAR SYSTEM (P040048/S005)Zimmer, Inc.2008-05-16
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S004)Microport Orthopedics, Inc.2008-05-08
HYALGAN (P950027/S009)Fidia Farmaceutici S.P.A.2008-05-01
PRODISC-C TOTAL DISC REPLACEMENT (P070001/S001)Centinel Spine, LLC2008-04-30
ASCENSION ORTHOPEDICS MCP (P000057/S004)Smith & Nephew, Inc.2008-04-24
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S012)Biomet Manufacturing Corp2008-04-23
TRILOGY AB ACETABULAR SYSTEM (P040048/S003)Zimmer, Inc.2008-04-11
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S027)Medtronic Sofamor Danek USA, Inc.2008-03-21
INFUSE BONE GRAFT (P000054/S016)Medtronic Sofamor Danek USA, Inc.2008-03-17
LCS TOTAL KNEE SYSTEM (P830055/S101)Depuy, Inc.2008-03-13
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE KNEE SYSTEMS (P060037/S001)Zimmer, Inc.2008-02-28
OXFORD PARTIAL KNEE (P010014/S018)Biomet Manufacturing Corp2008-02-25
OXFORD MENISCAL UNICOMPARTMENTAL KNEE (P010014/S017)Biomet Manufacturing Corp2008-02-20
PRODISC-L TOTAL DISC REPLACEMENT (P050010/S001)Centinel Spine, LLC2008-01-25
BIOMET BHS- MINI (P790002/S025)Ahp Eos Buyer, Inc.2008-01-17
INFUSE BONE GRAFT (P000054/S013)Medtronic Sofamor Danek USA, Inc.2008-01-14
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S025)Medtronic Sofamor Danek USA, Inc.2008-01-14
HYALGAN (P950027/S010)Fidia Farmaceutici S.P.A.2008-01-08
INFUSE BONE GRAFT (P000054/S009)Medtronic Sofamor Danek USA, Inc.2007-12-21
INFUSE BONE GRAFT/LT-CAGE TAPERED FUSION DEVICE (P000058/S020)Medtronic Sofamor Danek USA, Inc.2007-12-21
INFUSE BONE GRAFT/ LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S022)Medtronic Sofamor Danek USA, Inc.2007-12-20
PRODISC TM-C TOTAL DISC REPLACEMENT (P070001)Centinel Spine, LLC2007-12-17
X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S008)Medtronic Sofamor Danek, Inc.2007-12-14
OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE (P910066/S024)Djo, LLC2007-12-10
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037)Zimmer, Inc.2007-12-10
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
X-STOP INTERSPINOUS DECOMPRESSION SYSTEM (P040001/S005)Medtronic Sofamor Danek, Inc.2007-11-20
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