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Orthopedic

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

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RecordFirmDate
CERAMAX CERAMIC HIP SYSTEM (P070026/S030)DePuy Orthopaedics, Inc.2015-08-21
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S028)Smith & Nephew, Inc.2015-08-10
COFLEX INTERLAMINAR TECHNOLOGY (P110008/S003)Companion Spine France2015-08-05
GEL-ONE (P080020/S014)Seikagaku Corp.2015-08-03
SYNVISC, SYNVISC-ONE (P940015/S034)Sanofi Genzyme Corp.2015-07-24
OL1000, OL1000 SC, SPINALOGIC (P910066/S027)Djo, LLC2015-07-24
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE (P060037/S037)Zimmer, Inc.2015-07-23
ZIMMER NEXGEN LPS-MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S036)Zimmer, Inc.2015-07-17
SUPARTZ FX (P980044/S026)Seikagaku Corp.2015-07-16
GEL-ONE (P080020/S015)Seikagaku Corp.2015-07-16
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S056)Medtronic Sofamor Danek USA, Inc.2015-07-15
INFUSE BONE GRAFT (P000054/S042)Medtronic Sofamor Danek USA, Inc.2015-07-15
LCS TOTAL KNEE SYSTEM (P830055/S163)Depuy, Inc.2015-07-15
THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO (P850022/S024)Ahp Eos Buyer, Inc.2015-07-15
LCS TOTAL KNEE SYSTEM (P830055/S162)Depuy, Inc.2015-07-14
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S031)Zimmer, Inc.2015-07-02
MOBI-C CERVICAL DISC PROSTHESIS (P110002/S012)Highridge Medical, LLC2015-06-30
MOBI-C CERVICAL DISC PROSTHESIS (P110009/S012)Highridge Medical, LLC2015-06-30
LCS TOTAL KNEE SYSTEM (P830055/S159)Depuy, Inc.2015-06-25
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S013)Ceramtec GmbH2015-06-19
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S012)Ceramtec GmbH2015-06-11
ACTIVL ARTIFICIAL DISC (P120024)Highridge Medical, LLC2015-06-11
LCS TOTAL KNEE SYSTEM (P830055/S157)Depuy, Inc.2015-06-05
SYNVISC (P940015/S035)Sanofi Genzyme Corp.2015-05-26
LCS TOTAL KNEE SYSTEM (P830055/S156)Depuy, Inc.2015-05-26
SUPERION INTERSPINOUS SPACER (P140004)Boston Scientific Neuromodulation2015-05-20
SUPARTZ FX (P980044/S025)Seikagaku Corp.2015-05-20
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S024)Ferring Pharmaceuticals, Inc.2015-05-07
OXFORD PARTIAL KNEE SYSTEM (P010014/S051)Biomet Manufacturing Corp2015-05-06
MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES (P090031/S004)Anika Therapeutics, Inc.2015-05-05
ORTHOVISC INJECTABLE INTRA-ARTICULAR DEVICES (P030019/S022)Anika Therapeutics, Inc.2015-05-05
LCS TOTAL KNEE SYSTEM (P830055/S158)Depuy, Inc.2015-04-29
INFUSE BONE GRAFT (P000054/S043)Medtronic Sofamor Danek USA, Inc.2015-04-24
INFUSE BONE GRAFT LUMBAR TAPERED FUSION DEVICE (P000058/S057)Medtronic Sofamor Danek USA, Inc.2015-04-24
EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S039)Bioventus, LLC2015-04-22
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEE (P060037/S035)Zimmer, Inc.2015-04-15
PRESTIGE (R) LP CERVICAL DISC (P090029/S001)Medtronic Sofamor Danek USA, Inc.2015-04-06
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S023)Ferring Pharmaceuticals, Inc.2015-04-02
SUPARTZ (P980044/S024)Seikagaku Corp.2015-03-31
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S034)Zimmer, Inc.2015-03-27
LCS TOTAL KNEE SYSTEM (P830055/S155)Depuy, Inc.2015-03-25
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S011)Ceramtec GmbH2015-03-25
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S029)DePuy Orthopaedics, Inc.2015-03-25
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S028)DePuy Orthopaedics, Inc.2015-03-20
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S024)DePuy Orthopaedics, Inc.2015-03-18
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S022)Ferring Pharmaceuticals, Inc.2015-03-12
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S026)DePuy Orthopaedics, Inc.2015-03-12
ZIMMER NEXGEN LPS-FLEX AND LPS MOBILE BEARING KNEES (P060037/S032)Zimmer, Inc.2015-03-10
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S025)DePuy Orthopaedics, Inc.2015-03-10
OXFORD PARTIAL KNEE SYSTEM (P010014/S050)Biomet Manufacturing Corp2015-02-19
MOBI-C CERVICAL DISC PROSTHESIS (P110002/S009)Highridge Medical, LLC2015-02-05
MOBI-C CERVICAL DISC PROSTHESIS (P110009/S009)Highridge Medical, LLC2015-02-05
MONOVISC (P090031/S003)Anika Therapeutics, Inc.2015-02-04
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S023)DePuy Orthopaedics, Inc.2015-01-30
INFUSE(R) BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S058)Medtronic Sofamor Danek USA, Inc.2015-01-27
EUFLEXXA (P010029/S021)Ferring Pharmaceuticals, Inc.2015-01-21
LCS TOTAL KNEE SYSTEM (P830055/S154)Depuy, Inc.2015-01-21
TRUMATCH SOLUTIONS (P830055/S152)Depuy, Inc.2014-12-31
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S033)Zimmer, Inc.2014-12-30
MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S008)Highridge Medical, LLC2014-12-29
MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) (P110009/S008)Highridge Medical, LLC2014-12-29
PRODISC -C TOTAL DISC REPLACEMENT (P070001/S012)Centinel Spine, LLC2014-12-22
NU VASIVE PCM CERVICAL DISC SYSTEM (P100012/S006)Nuvasive, Inc.2014-12-19
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005)Globus Medical, Inc.2014-12-18
LCS TOTAL KNEE SYSTEM (P830055/S153)Depuy, Inc.2014-12-18
SUPARTZ (P980044/S023)Seikagaku Corp.2014-12-17
SUPARTZ (P980044/S021)Seikagaku Corp.2014-12-17
SUPARTZ (P980044/S022)Seikagaku Corp.2014-12-17
SUPARTZ (P980044/S020)Seikagaku Corp.2014-12-17
X-STOP LTOS (P040001/S021)Medtronic Sofamor Danek, Inc.2014-12-12
EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S038)Bioventus, LLC2014-12-08
LCS TOTAL KNEE SYSTEM (P830055/S150)Depuy, Inc.2014-12-08
OXFORD PARTIAL KNEE SYSTEM (P010014/S049)Biomet Manufacturing Corp2014-11-13
GEL-ONE (P080020/S013)Seikagaku Corp.2014-10-30
X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022)Medtronic Sofamor Danek, Inc.2014-10-24
R3 ACETABULAR SHELLS (P030022/S031)Smith & Nephew, Inc.2014-10-17
LCS TOTAL KNEE SYSTEM (P830055/S151)Depuy, Inc.2014-10-10
LCS TOTAL KNEE SYSTEM (P830055/S149)Depuy, Inc.2014-10-08
SUPARTZ (P980044/S019)Seikagaku Corp.2014-09-26
SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S038)Ahp Eos Buyer, Inc.2014-09-19
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S051)Ahp Eos Buyer, Inc.2014-09-19
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S027)Smith & Nephew, Inc.2014-09-05
LCS TOTAL KNEE SYSTEM (P830055/S147)Depuy, Inc.2014-08-29
THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO (P850022/S023)Ahp Eos Buyer, Inc.2014-08-28
GEL-ONE (P080020/S011)Seikagaku Corp.2014-08-28
GEL-ONE (P080020/S012)Seikagaku Corp.2014-08-28
GEL ONE (P080020/S010)Seikagaku Corp.2014-08-28
SYNTHES PRODISC-C TOTAL DISC REPLACEMENT (P070001/S013)Centinel Spine, LLC2014-08-27
SYNTHES PRODISC-L TOTAL DISC REPLACEMENT (P050010/S016)Centinel Spine, LLC2014-08-27
CERVICAL-STIM (P030034/S007)Orthofix, Inc.2014-08-27
PHYSIO-STIM AND SPINAL-STIM (P850007/S033)Orthofix, Inc.2014-08-27
GEL-ONE (P080020/S009)Seikagaku Corp.2014-08-25
SYNVISC, SYNVISC-ONE (P940015/S033)Sanofi Genzyme Corp.2014-08-21
EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S037)Bioventus, LLC2014-08-21
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S030)Zimmer, Inc.2014-08-14
BIRMINGHAM HIP RESURFACING SYSTEM (P040033/S025)Smith & Nephew, Inc.2014-08-12
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEES (P060037/S021)Zimmer, Inc.2014-08-11
LCS TOTAL KNEE SYSTEM (P830055/S146)Depuy, Inc.2014-08-08
SYNVISC AND SYNVISC ONE (P940015/S029)Sanofi Genzyme Corp.2014-08-06
PRODISC-L (P050010/S013)Centinel Spine, LLC2014-07-31
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