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Orthopedic

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

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RecordFirmDate
R3 Delta Ceramic Hip System (P150030/S018)Smith & Nephew, Inc.2021-12-20
Oxford Partial Knee System (P010014/S098)Biomet Manufacturing Corp2021-12-17
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S020)Djo Global2021-12-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S073)Zimmer, Inc.2021-12-15
Cartiva Synthetic Cartilage Implant (SCI) (P150017/S015)Cartiva, Inc.2021-12-10
LCS® Total Knee System (P830055/S276)Depuy, Inc.2021-12-09
CERAMAX (R) Ceramic Total Hip System (P070026/S088)DePuy Orthopaedics, Inc.2021-12-09
R3 DELTA CERAMIC HIP SYSTEM (P150030/S017)Smith & Nephew, Inc.2021-12-08
LCS Total Knee System (P830055/S273)Depuy, Inc.2021-11-20
SUPARTZ FX, VISCO-3 (P980044/S058)Seikagaku Corp.2021-11-17
Gel-One (P080020/S046)Seikagaku Corp.2021-11-17
AUGMENT Bone Graft and AUGMENT Injectable (P100006/S012)Biomimetic Therapeutics, LLC2021-11-17
R3 Delta Ceramic Hip System (P150030/S013)Smith & Nephew, Inc.2021-11-10
LCS Total Knee System (P830055/S272)Depuy, Inc.2021-11-10
R3 DELTA CERAMIC HIP SYSTEM (P150030/S015)Smith & Nephew, Inc.2021-11-09
Infuse Bone Graft (P000054/S060)Medtronic Sofamor Danek USA, Inc.2021-11-08
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S079)Medtronic Sofamor Danek USA, Inc.2021-11-08
CERAMAX Ceramic Total Hip System (P070026/S087)DePuy Orthopaedics, Inc.2021-11-05
Mobi-C® Cervical Disc Prosthesis (two-level use) (P110009/S031)Highridge Medical, LLC2021-11-01
Mobi-C® Cervical Disc Prosthesis (one-level use) (P110002/S031)Highridge Medical, LLC2021-11-01
prodisc® C (P070001/S021)Centinel Spine, LLC2021-10-28
SYNVISC and SYNVISC ONE (P940015/S047)Sanofi Genzyme Corp.2021-10-27
Hintermann Series H3 Total Ankle Replacement System (P160036/S003)Dt Medtech, LLC2021-10-15
Monovisc High Molecular Weight Hyaluronan (P090031/S011)Anika Therapeutics, Inc.2021-10-13
Monovisc High Molecular Weight Hyaluronan (P090031/S012)Anika Therapeutics, Inc.2021-10-13
M6-C Artificial Cervial Disc (P170036/S009)Spinal Kinetics, LLC2021-10-12
Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit (P140004/S026)Boston Scientific Neuromodulation2021-10-07
Transcend Hip Articulation System (P010001/S024)Ceramtec GmbH2021-10-07
NexGen® LPS-Flex / LPS-Mobile Bearing Knee System (P060037/S075)Zimmer, Inc.2021-10-07
GEL-ONE (P080020/S045)Seikagaku Corp.2021-10-04
LCS Total Knee System (P830055/S275)Depuy, Inc.2021-10-01
LCS Total Knee System (P830055/S263)Depuy, Inc.2021-09-21
LCS Total Knee System (P830055/S274)Depuy, Inc.2021-09-10
CERAMAX® Ceramic Total Hip System (P070026/S085)DePuy Orthopaedics, Inc.2021-09-10
Monovisc High Molecular Weight Hyaluronan (P090031/S010)Anika Therapeutics, Inc.2021-09-03
Synvisc, Synvisc-One (P940015/S049)Sanofi Genzyme Corp.2021-09-03
GELSYN-3 (P110005/S009)Ibsa Institut Biochimique SA2021-09-02
EXOGEN Ultrasound Bone Healing System (P900009/S047)Bioventus, LLC2021-08-31
Superion™ Indirect Decompression System (IDS) (P140004/S025)Boston Scientific Neuromodulation2021-08-26
Scandinavian Total Ankle Replacement (S.T.A.R. Ankle) (P050050/S019)Djo Global2021-08-23
LCS® Total Knee System (P830055/S271)Depuy, Inc.2021-08-19
CERAMAX® Total Hip System (P070026/S084)DePuy Orthopaedics, Inc.2021-08-19
NexGen LPS-Flex / LPS-Mobile Bearing Knee (P060037/S074)Zimmer, Inc.2021-08-17
M6-C Artificial Cervical Disc (P170036/S008)Spinal Kinetics, LLC2021-08-06
Gel-One (P080020/S044)Seikagaku Corp.2021-08-06
SUPARTZ FX and VISCO-3 (P980044/S057)Seikagaku Corp.2021-08-06
Simplify Cervical Artificial Disc (P200022/S001)Nuvasive, Inc.2021-08-03
LCS Total Knee System (P830055/S270)Depuy, Inc.2021-08-02
Simplify Cervical Artificial Disc (P200022/S007)Nuvasive, Inc.2021-07-21
CERAMAX Ceramic Total Hip System (P070026/S083)DePuy Orthopaedics, Inc.2021-07-20
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S072)Zimmer, Inc.2021-07-19
LCS Total Knee System (P830055/S268)Depuy, Inc.2021-07-07
CERAMAX Ceramic Total Hip System (P070026/S082)DePuy Orthopaedics, Inc.2021-07-07
Orthovisc (P030019/S026)Anika Therapeutics, Inc.2021-07-02
LCS Total Knee System (P830055/S269)Depuy, Inc.2021-06-30
Transcend Hip Articulation System (P010001/S023)Ceramtec GmbH2021-06-30
R3 Delta Ceramic Hip System (P150030/S009)Smith & Nephew, Inc.2021-06-30
R3 Delta Ceramic Acetabular System (P150030/S010)Smith & Nephew, Inc.2021-06-30
Synvisc and Synvisc-One (P940015/S048)Sanofi Genzyme Corp.2021-06-29
R3 Delta Ceramic Acetabular System (P150030/S011)Smith & Nephew, Inc.2021-06-29
LCS Total Knee System (P830055/S267)Depuy, Inc.2021-06-14
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S071)Zimmer, Inc.2021-06-14
Simplify® Cervical Artificial Disc (2 Level) (P200022/S005)Nuvasive, Inc.2021-05-28
Gel-One (P080020/S043)Seikagaku Corp.2021-05-26
Simplify® Cervical Artificial Disc (One-Level) (P200022/S006)Nuvasive, Inc.2021-05-26
DUROLANE (P170007/S009)Bioventus, LLC2021-05-25
SUPARTZ device family, SUPARTZ FX and VISCO-3 (P980044/S056)Seikagaku Corp.2021-05-24
LCS Total Knee System (P830055/S265)Depuy, Inc.2021-05-10
CERAMAX Ceramic Total Hip System (P070026/S081)DePuy Orthopaedics, Inc.2021-05-05
LCS Total Knee System (P830055/S266)Depuy, Inc.2021-05-05
Mobi-C® Cervical Disc Prosthesis Two-Level (P110009/S030)Highridge Medical, LLC2021-05-05
Mobi-C® Cervical Disc Prosthesis One-Level (P110002/S030)Highridge Medical, LLC2021-05-05
CERAMAX Ceramic Total Hip System (P070026/S080)DePuy Orthopaedics, Inc.2021-04-30
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S018)Djo Global2021-04-19
SUPARTZ device family, SUPARTZ FX and VISCO-3 (P980044/S055)Seikagaku Corp.2021-04-15
Gel-One (P080020/S042)Seikagaku Corp.2021-04-15
EXOGEN Ultrasound Bone Healing System (P900009/S046)Bioventus, LLC2021-04-14
INFUSE Bone Graft (P000054/S065)Medtronic Sofamor Danek USA, Inc.2021-04-05
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S084)Medtronic Sofamor Danek USA, Inc.2021-04-05
Simplify Cervical Artificial Disc (P200022/S003)Nuvasive, Inc.2021-04-01
coflex Interlaminar Stabilization Device (P110008/S013)Companion Spine France2021-03-31
GELSYN-3 (P110005/S008)Ibsa Institut Biochimique SA2021-03-15
prodisc L (P050010/S023)Centinel Spine, LLC2021-03-15
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S017)Djo Global2021-03-15
Hintermann Series H3 Total Ankle Replacement System (P160036/S002)Dt Medtech, LLC2021-03-11
Trident Ceramic System (P000013/S018)Howmedica Osteonics Corp.2021-03-05
prodisc C (P070001/S020)Centinel Spine, LLC2021-02-23
LCS Total Knee System (P830055/S262)Depuy, Inc.2021-02-19
Mobi-C Cervical Disc Prosthesis One-level (P110002/S029)Highridge Medical, LLC2021-02-17
Mobi-C Cervical Disc Prosthesis Two-level (P110009/S029)Highridge Medical, LLC2021-02-17
SpF Implantable Spinal Fusion Stimulators (P850035/S056)Ahp Eos Buyer, Inc.2021-02-17
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S067)Ahp Eos Buyer, Inc.2021-02-17
OPRA Implant System (P190009/S001)Integrum AB2021-02-12
OPRA System (P190009/S002)Integrum AB2021-02-12
Simplify Cervical Artificial Disc (P200022/S004)Nuvasive, Inc.2021-02-10
Infuse Bone Graft (P000054/S064)Medtronic Sofamor Danek USA, Inc.2021-02-05
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S083)Medtronic Sofamor Danek USA, Inc.2021-02-05
Scandinavian Total Ankle Replacment (STAR Ankle) (P050050/S016)Djo Global2021-01-13
Infuse Bone Graft (P000054/S061)Medtronic Sofamor Danek USA, Inc.2020-12-30
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S080)Medtronic Sofamor Danek USA, Inc.2020-12-30
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