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Orthopedic

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

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RecordFirmDate
Oxford™ Cementless Partial Knee System (P010014/S105)Biomet Manufacturing Corp2024-11-22
Oxford Partial Knee System (P010014/S108)Biomet Manufacturing Corp2024-11-18
ActaStim-S Spine Fusion Stimulator (P190030/S003)Theragen, Inc.2024-11-13
ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revi (P830055/S330)Depuy, Inc.2024-11-13
Xstim Spine Fusion Stimulator (P230025/S001)Xstim, Inc.2024-11-12
CERAMAX Ceramic Hip System (P070026/S115)DePuy Orthopaedics, Inc.2024-11-08
LCS Total Knee System (P830055/S336)Depuy, Inc.2024-11-08
Superion Indirect Decompression System (IDS) System (P140004/S034)Boston Scientific Neuromodulation2024-11-07
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S093)Medtronic Sofamor Danek USA, Inc.2024-11-06
INFUSE™ Bone Graft (P000054/S073)Medtronic Sofamor Danek USA, Inc.2024-11-06
CERAMAX Ceramic Total Hip System (P070026/S113)DePuy Orthopaedics, Inc.2024-10-23
Transcend® Hip Articulation System (P010001/S028)Ceramtec GmbH2024-10-16
HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan) (P150010/S004)Fidia Farmaceutici2024-10-16
LCS Total Knee System (P830055/S335)Depuy, Inc.2024-10-15
LCS Total Knee System (P830055/S333)Depuy, Inc.2024-10-03
EUFLEXXA (P010029/S040)Ferring Pharmaceuticals, Inc.2024-09-23
LCS® Total Knee System (P830055/S331)Depuy, Inc.2024-09-20
Hintermann Series H3 Total Ankle Replacement System (P160036/S005)Dt Medtech, LLC2024-09-20
SpF® Implantable Spinal Fusion Stimulators (P850035/S059)Ahp Eos Buyer, Inc.2024-09-20
LCS® Total Knee System (P830055/S332)Depuy, Inc.2024-09-19
R3TM delta Ceramic Acetabular System (P150030/S043)Smith & Nephew, Inc.2024-09-13
i-FACTOR® Peptide Enhanced Bone Graft (P140019/S011)Cerapedics, LLC2024-09-13
R3TM DELTA CERAMIC ACETABULAR SYSTEM (P150030/S044)Smith & Nephew, Inc.2024-09-10
R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products (P150030/S042)Smith & Nephew, Inc.2024-08-30
LCS (R) Total Knee System (P830055/S329)Depuy, Inc.2024-08-27
Superion Indirect Decompression System (P140004/S033)Boston Scientific Neuromodulation2024-08-22
Oxford® Partial Knee System (P010014/S106)Biomet Manufacturing Corp2024-08-19
M6-C Artificial Cervical Disc (P170036/S016)Spinal Kinetics, LLC2024-08-19
EUFLEXXA (P010029/S039)Ferring Pharmaceuticals, Inc.2024-08-17
Prestige LP (R) Cervical Disc (P090029/S021)Medtronic Sofamor Danek USA, Inc.2024-08-09
prodisc C (P070001/S027)Centinel Spine, LLC2024-08-07
CERAMAX® Ceramic Total Hip System (P070026/S112)DePuy Orthopaedics, Inc.2024-08-06
LCS® Total Knee System (P830055/S327)Depuy, Inc.2024-08-06
LCS(R) Total Knee System (P830055/S328)Depuy, Inc.2024-08-01
LCS( Total Knee System (P830055/S326)Depuy, Inc.2024-07-25
SUPARTZ FX, VISCO-3 (P980044/S062)Seikagaku Corp.2024-07-25
R3 DELTA Ceramic Hip System (P150030/S041)Smith & Nephew, Inc.2024-07-23
AccelStim™ (P210035/S002)Orthofix US, LLC2024-07-11
M6-C Artificial Cervical Disc (P170036/S015)Spinal Kinetics, LLC2024-07-10
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb (P160050/S009)Intrinsic Therapeutics2024-07-03
HYALGAN® (P950027/S019)Fidia Farmaceutici S.P.A.2024-06-28
HYMOVIS® (P150010/S003)Fidia Farmaceutici2024-06-28
TRILURON® (P180040/S005)Fidia Farmaceutici S.P.A.2024-06-28
R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S040)Smith & Nephew, Inc.2024-06-27
LCS Total Knee System (P830055/S324)Depuy, Inc.2024-06-21
TOPS™ System (P220002/S004)Premia Spine, Ltd.2024-06-20
M6-C Artificial Cervical Disc (P170036/S014)Spinal Kinetics, LLC2024-06-14
LCS® Total Knee System (P830055/S322)Depuy, Inc.2024-05-31
LCS Total Knee System (P830055/S323)Depuy, Inc.2024-05-31
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
Prestige LP (R) Cervical Disc (P090029/S020)Medtronic Sofamor Danek USA, Inc.2024-05-01
R3 Delta Ceramic Hip System (P150030/S036)Smith & Nephew, Inc.2024-04-29
Simplify® Cervical Artificial Disc (P200022/S013)Nuvasive, Inc.2024-04-17
OPRA Implant System (P190009/S005)Integrum AB2024-04-09
EUFLEXXA (P010029/S038)Ferring Pharmaceuticals, Inc.2024-04-06
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
TRANSCEND® Hip Articulation System (P010001/S027)Ceramtec GmbH2024-03-27
Ascension MCP (P000057/S012)Smith & Nephew, Inc.2024-03-20
R3™ Delta Ceramic Hip System (P150030/S039)Smith & Nephew, Inc.2024-03-20
LCS® Total Knee System (P830055/S313)Depuy, Inc.2024-03-15
Scandinavian Total Ankle Replacement (STAR) (P050050/S026)Djo Global2024-03-13
Trident® Acetabular System (P000013/S025)Howmedica Osteonics Corp.2024-03-08
EUFLEXXA (P010029/S037)Ferring Pharmaceuticals, Inc.2024-03-01
prodisc - C and prodisc - C Nova (Indicated for Single Level Use) (P070001/S026)Centinel Spine, LLC2024-03-01
Superion Indirect Decompression System (IDS) (P140004/S032)Boston Scientific Neuromodulation2024-02-29
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy (P850022/S034)Ahp Eos Buyer, Inc.2024-02-29
LCS® Total Knee System (P830055/S311)Depuy, Inc.2024-02-27
LCS(R) Total Knee System (P830055/S319)Depuy, Inc.2024-02-22
Prestige LP Cervical Disc (P090029/S018)Medtronic Sofamor Danek USA, Inc.2024-02-21
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13
Xstim Spine Fusion Stimulator (P230025)Xstim, Inc.2024-02-09
Barricaid® Annular Closure Device (P160050/S008)Intrinsic Therapeutics2024-02-08
EUFLEXXA® (1% sodium hyaluronate) (P010029/S036)Ferring Pharmaceuticals, Inc.2024-02-02
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S087)Zimmer, Inc.2024-02-01
CERAMAX® Ceramic Total Hip System (P070026/S111)DePuy Orthopaedics, Inc.2024-01-29
activL Artificial Disc (P120024/S013)Highridge Medical, LLC2024-01-26
Trident(R), ABC(R) (P000013/S024)Howmedica Osteonics Corp.2024-01-23
R3 Delta Ceramic Hip System (P150030/S037)Smith & Nephew, Inc.2024-01-19
Birmingham Hip Resurfacing (BHR) System (P040033/S038)Smith & Nephew, Inc.2024-01-19
LCS Total Knee System (P830055/S318)Depuy, Inc.2024-01-12
Gelsyn-3 (P110005/S014)Ibsa Institut Biochimique SA2024-01-11
LCS Total Knee System, ATTUNE Revision Cones (P830055/S316)Depuy, Inc.2023-12-22
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S086)Zimmer, Inc.2023-12-22
EXOGEN® Ultrasound Bone Healing System (P900009/S049)Bioventus, LLC2023-12-21
OPRA Implant System (P190009/S004)Integrum AB2023-12-21
Trident Ceramic System (P000013/S021)Howmedica Osteonics Corp.2023-12-20
LCS® Total Knee System (P830055/S310)Depuy, Inc.2023-12-19
Trident(R), ABC(R) (P000013/S023)Howmedica Osteonics Corp.2023-12-19
Cermax® Ceramic Total Hip System (P070026/S109)DePuy Orthopaedics, Inc.2023-12-19
I-FACTOR Peptide Enhanced Bone Graft (P140019/S010)Cerapedics, LLC2023-12-15
R3 Delta Ceramic Hip System (P150030/S038)Smith & Nephew, Inc.2023-12-13
Gel-One (P080020/S052)Seikagaku Corp.2023-12-08
LCS® Total Knee System (P830055/S317)Depuy, Inc.2023-11-28
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S085)Zimmer, Inc.2023-11-21
LCS Total Knee System (P830055/S309)Depuy, Inc.2023-11-17
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S024)Djo Global2023-11-13
prodisc® L (P050010/S024)Centinel Spine, LLC2023-11-08
prodisc® C (P070001/S024)Centinel Spine, LLC2023-11-08
Hintermann Series H3 Total Ankle Replacement System (P160036/S004)Dt Medtech, LLC2023-11-06
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