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Orthopedic

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

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RecordFirmDate
Mobi-C Cervical Disc Prosthesis (P110009/S023)Highridge Medical, LLC2020-02-18
Mobi-C Cervical Disc Prosthesis (P110002/S023)Highridge Medical, LLC2020-02-18
Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S013)Cartiva, Inc.2020-02-09
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S021)Ceramtec GmbH2020-02-04
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S073)Medtronic Sofamor Danek USA, Inc.2020-02-04
Infuse Bone Graft (P000054/S054)Medtronic Sofamor Danek USA, Inc.2020-02-04
Aesculap activL Artificial Disc (P120024/S011)Highridge Medical, LLC2020-01-31
M6-C Artificial Cervical Disc (P170036/S004)Spinal Kinetics, LLC2020-01-31
CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic) (P910066/S031)Djo, LLC2020-01-23
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S022)Ceramtec GmbH2020-01-22
Synvisc/Synvisc-One (P940015/S045)Sanofi Genzyme Corp.2020-01-16
Monovisc (P090031/S009)Anika Therapeutics, Inc.2020-01-09
Euflexxa (1% Sodium Hyaluronate) (P010029/S029)Ferring Pharmaceuticals, Inc.2020-01-02
LCS Total Knee System (P830055/S242)Depuy, Inc.2020-01-02
LCS(R) Total Knee System (P830055/S239)Depuy, Inc.2019-12-23
LCS Total Knee System (P830055/S236)Depuy, Inc.2019-12-23
CERAMAX Ceramic Total Hip System (P070026/S068)DePuy Orthopaedics, Inc.2019-12-23
Exogen Ultrasound Bone Healing System (P900009/S044)Bioventus, LLC2019-12-20
Durolane, Hyaluronic Acid, Stabilized Single Injection (P170007/S005)Bioventus, LLC2019-12-18
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S074)Medtronic Sofamor Danek USA, Inc.2019-12-13
Infuse Bone Graft (P000054/S055)Medtronic Sofamor Danek USA, Inc.2019-12-13
AUGMENT Bone Graft and AUGMENT Injectable (P100006/S011)Biomimetic Therapeutics, LLC2019-12-06
prodisc L (P050010/S022)Centinel Spine, LLC2019-12-05
INFUSE Bone Graft (P000054/S058)Medtronic Sofamor Danek USA, Inc.2019-12-04
LCS Total Knee System (P830055/S240)Depuy, Inc.2019-12-04
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S077)Medtronic Sofamor Danek USA, Inc.2019-12-04
LCS(R) Total Knee System (P830055/S241)Depuy, Inc.2019-12-03
LCS Total Knee System (P830055/S238)Depuy, Inc.2019-12-03
Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys (P850022/S030)Ahp Eos Buyer, Inc.2019-12-03
Superion Indirect Decompression System (P140004/S016)Boston Scientific Neuromodulation2019-12-02
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S076)Medtronic Sofamor Danek USA, Inc.2019-11-29
Infuse Bone Graft (P000054/S057)Medtronic Sofamor Danek USA, Inc.2019-11-29
CERAMAX Ceramic Total Hip System (P070026/S059)DePuy Orthopaedics, Inc.2019-11-29
Hintermann Series H3 Total Ankle Replacement System (P160036/S001)Dt Medtech, LLC2019-11-29
Cartiva Synthetic Cartilage Implant (P150017/S014)Cartiva, Inc.2019-11-26
LCS(R) Total Knee System (P830055/S235)Depuy, Inc.2019-11-21
LCS Total Knee System (P830055/S237)Depuy, Inc.2019-11-14
Mobi-C Cervical Disc Prosthesis (for Two-Level) (P110009/S022)Highridge Medical, LLC2019-11-13
Mobi-C Cervical Disc Prosthesis (one-level indications) (P110002/S022)Highridge Medical, LLC2019-11-13
Ceramax Ceramic Total Hip System (P070026/S069)DePuy Orthopaedics, Inc.2019-11-07
Oxford Partial Knee System (P010014/S096)Biomet Manufacturing Corp2019-11-05
INFUSE Bone Graft (P000054/S056)Medtronic Sofamor Danek USA, Inc.2019-11-01
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S075)Medtronic Sofamor Danek USA, Inc.2019-11-01
Gel-One (P080020/S035)Seikagaku Corp.2019-10-30
CERAMAX Ceramic Total Hip System (P070026/S062)DePuy Orthopaedics, Inc.2019-10-27
Ceramax Ceramic Total Hip System (P070026/S061)DePuy Orthopaedics, Inc.2019-10-27
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S065)Ahp Eos Buyer, Inc.2019-10-24
SpF Implantable Spinal Fusion Stimulators (P850035/S054)Ahp Eos Buyer, Inc.2019-10-24
NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S062)Zimmer, Inc.2019-10-24
S.T.A.R Ankle System (P050050/S012)Djo Global2019-10-21
i-FACTOR Peptide Enhanced Bone Graft (P140019/S003)Cerapedics, LLC2019-10-11
Oxford Partial Knee System (P010014/S094)Biomet Manufacturing Corp2019-10-09
CervicalStim (P030034/S015)Orthofix, Inc.2019-10-08
PhysioStim and SpinalStim (P850007/S043)Orthofix, Inc.2019-10-08
Oxford Partial Knee System (P010014/S093)Biomet Manufacturing Corp2019-09-27
Durolane (P170007/S004)Bioventus, LLC2019-09-19
Oxford Partial Knee System (P010014/S092)Biomet Manufacturing Corp2019-09-12
AUGMENT Bone Graft and AUGMENT Injectable (P100006/S009)Biomimetic Therapeutics, LLC2019-09-11
Oxford Partial Knee System (P010014/S091)Biomet Manufacturing Corp2019-09-11
Superion Indirect Decompression System (P140004/S014)Boston Scientific Neuromodulation2019-09-10
M6-C Artificial Cervical Disc (P170036/S003)Spinal Kinetics, LLC2019-09-05
LCS(R) Total Knee System (P830055/S234)Depuy, Inc.2019-08-15
Ceramax Ceramic Total Hip System (P070026/S067)DePuy Orthopaedics, Inc.2019-08-14
Transcend Hip Articulation System (P010001/S020)Ceramtec GmbH2019-08-09
Nexgen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S061)Zimmer, Inc.2019-08-07
Oxford Partial Knee System (P010014/S090)Biomet Manufacturing Corp2019-08-06
CERAMAX CERAMIC HIP SYSTEM (P070026/S065)DePuy Orthopaedics, Inc.2019-08-06
Bone Growth Stimulators (P910066/S030)Djo, LLC2019-08-02
M6-C Artificial Cervical Disc (P170036/S001)Spinal Kinetics, LLC2019-08-02
LCS Total Knee System - Attune Revision Tibial Sleeves (P830055/S233)Depuy, Inc.2019-08-01
LCS Total Knee System (P830055/S231)Depuy, Inc.2019-07-29
NexGen LPS-Flex and LPS Mobile Bearing Knee System (P060037/S059)Zimmer, Inc.2019-07-29
Infuse Bone Graft and Medtronic Interbody Fusion Device (P000058/S072)Medtronic Sofamor Danek USA, Inc.2019-07-24
Infuse Bone Graft (P000054/S053)Medtronic Sofamor Danek USA, Inc.2019-07-24
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S058)Zimmer, Inc.2019-07-22
Oxford Partial Knee System (P010014/S089)Biomet Manufacturing Corp2019-07-19
Ceramax Ceramic Total Hip System (P070026/S063)DePuy Orthopaedics, Inc.2019-07-19
SpF Implantable Spinal Fusion Stimulators (P850035/S055)Ahp Eos Buyer, Inc.2019-07-18
OsteoGen Surigically Implantable Bone Growth Stimulators (P790005/S066)Ahp Eos Buyer, Inc.2019-07-18
Prestige LP Cervical Disc – Two Level (P090029/S012)Medtronic Sofamor Danek USA, Inc.2019-07-12
Cartiva Synthetic Cartilage Implant (P150017/S011)Cartiva, Inc.2019-07-12
Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S010)Cartiva, Inc.2019-07-11
SpinalStim (P850007/S042)Orthofix, Inc.2019-07-03
NexGen LPS-Flex/LPS-Mobile Bearing Knee System (P060037/S060)Zimmer, Inc.2019-07-03
AUGMENT Bone Graft and AUGMENT Injectable (P100006/S007)Biomimetic Therapeutics, LLC2019-06-28
Osteonics ABC/Trident Systems (P000013/S014)Howmedica Osteonics Corp.2019-06-21
PhysioStim and SpinalStim (P850007/S041)Orthofix, Inc.2019-06-18
CervicalStim (P030034/S014)Orthofix, Inc.2019-06-18
LCS Total Knee System (P830055/S232)Depuy, Inc.2019-06-13
AUGMENT Injectable (P100006/S008)Biomimetic Therapeutics, LLC2019-06-11
Durolane, Hyaluronic Acid, Stabilized Single Injection (P170007/S003)Bioventus, LLC2019-06-08
R3 delta Ceramic Acetabular System (P150030/S007)Smith & Nephew, Inc.2019-06-07
Hintermann Series H3 Total Ankle Replacement System (P160036)Dt Medtech, LLC2019-06-04
prodisc C Total Disc Replacement (P070001/S017)Centinel Spine, LLC2019-05-31
LCS Total Knee System (P830055/S230)Depuy, Inc.2019-05-17
Oxford Partial Knee System (P010014/S087)Biomet Manufacturing Corp2019-05-15
Oxford Partial Knee System (P010014/S088)Biomet Manufacturing Corp2019-05-15
activeL Artificial Disc (P120024/S008)Highridge Medical, LLC2019-05-13
LCS Total Knee System - ATTUNE Revision Femoral and Tibial Sleeves (P830055/S229)Depuy, Inc.2019-05-10
M6-C Artificial Cervical Disc (P170036/S002)Spinal Kinetics, LLC2019-05-10
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