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Orthopedic

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

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RecordFirmDate
LCS Total Knee System (P830055/S226)Depuy, Inc.2019-05-09
LCS Total Knee System (P830055/S220)Depuy, Inc.2019-05-09
EUFLEXXA (1% Sodium Hyaluronate) (P010029/S028)Ferring Pharmaceuticals, Inc.2019-05-08
Barricaid Anular Closure Device (P160050/S001)Intrinsic Therapeutics2019-05-07
Barricaid Anular Closure Device (P160050/S002)Intrinsic Therapeutics2019-05-03
Oxford Partial Knee System (P010014/S086)Biomet Manufacturing Corp2019-05-02
LCS Total Knee System (P830055/S228)Depuy, Inc.2019-04-30
Prestige LP Cervical Disc (P090029/S011)Medtronic Sofamor Danek USA, Inc.2019-04-26
Ceramax Ceramic Total Hip System (P070026/S060)DePuy Orthopaedics, Inc.2019-04-26
Ceramax Ceramic Total Hip System (P070026/S057)DePuy Orthopaedics, Inc.2019-04-24
LCS Total Knee System (P830055/S227)Depuy, Inc.2019-04-24
Oxford Partial Knee System (P010014/S085)Biomet Manufacturing Corp2019-04-17
CERAMAX Ceramic Total Hip System (P070026/S058)DePuy Orthopaedics, Inc.2019-04-17
Oxford Partial Knee System (P010014/S084)Biomet Manufacturing Corp2019-04-17
CERAMAX Ceramic Total Hip System (P070026/S056)DePuy Orthopaedics, Inc.2019-04-12
NuVasive PCM Cervical Disc (P100012/S008)Nuvasive, Inc.2019-04-03
LCS(R) Total Knee System (P830055/S210)Depuy, Inc.2019-03-27
TRILURON (P180040)Fidia Farmaceutici S.P.A.2019-03-26
Cartiva Synthetic Cartilage Implant (P150017/S012)Cartiva, Inc.2019-03-22
DUROLANE (P170007/S002)Bioventus, LLC2019-03-13
Gel-One (P080020/S032)Seikagaku Corp.2019-03-13
LCS Total Knee System (P830055/S225)Depuy, Inc.2019-03-13
LCS Total Knee System (P830055/S223)Depuy, Inc.2019-03-13
Gel-One (P080020/S033)Seikagaku Corp.2019-03-13
LCS Total Knee System (P830055/S222)Depuy, Inc.2019-03-08
LCS Total Knee System (P830055/S224)Depuy, Inc.2019-03-07
TRANSCEND Hip Articulation System (P010001/S019)Ceramtec GmbH2019-03-06
Ascension MCP (P000057/S011)Smith & Nephew, Inc.2019-03-05
R3 delta Ceramic Acetabular System (P150030/S006)Smith & Nephew, Inc.2019-02-19
BARRICAID ANULAR CLOSURE DEVICE (ACD) (P160050)Intrinsic Therapeutics2019-02-08
M6-C Artificial Cervical Disc (P170036)Spinal Kinetics, LLC2019-02-06
LCS(R) Total Knee System (P830055/S221)Depuy, Inc.2019-02-04
LCS(R) TruMatch Peronalized Solutions (P830055/S217)Depuy, Inc.2019-01-31
SUPARTZ FX; VISCO-3 (P980044/S051)Seikagaku Corp.2019-01-18
Synvisc One (P940015/S044)Sanofi Genzyme Corp.2019-01-16
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S071)Medtronic Sofamor Danek USA, Inc.2019-01-15
Infuse Bone Graft (P000054/S052)Medtronic Sofamor Danek USA, Inc.2019-01-15
Synvisc and Synvisc-One (P940015/S043)Sanofi Genzyme Corp.2019-01-10
LCS(R) Total Knee System (P830055/S213)Depuy, Inc.2019-01-08
Synvisc One (P940015/S042)Sanofi Genzyme Corp.2018-12-28
Osteonics ABC/Trident System (P000013/S016)Howmedica Osteonics Corp.2018-12-21
CervicalStim (P030034/S013)Orthofix, Inc.2018-12-20
PhysioStim/SpinalStim (P850007/S040)Orthofix, Inc.2018-12-20
LCS Total Knee System (P830055/S215)Depuy, Inc.2018-12-19
LCS Total Knee System Barcode Scanning (P830055/S219)Depuy, Inc.2018-12-14
R3 delta Ceramic Acetabular System (P150030/S005)Smith & Nephew, Inc.2018-12-07
Supartz FX and Visco-3 (P980044/S050)Seikagaku Corp.2018-12-06
Gel-One (P080020/S031)Seikagaku Corp.2018-12-06
NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S057)Zimmer, Inc.2018-12-05
Oxford Partial Knee System (P010014/S083)Biomet Manufacturing Corp2018-12-05
LCS Total Knee System (P830055/S211)Depuy, Inc.2018-12-03
LCS Total Knee System (P830055/S216)Depuy, Inc.2018-11-29
LCS Total Knee System (P830055/S218)Depuy, Inc.2018-11-28
Oxford Partial Knee System (P010014/S076)Biomet Manufacturing Corp2018-11-20
Oxford Partial Knee System (P010014/S081)Biomet Manufacturing Corp2018-11-20
EUFLEXXA (P010029/S027)Ferring Pharmaceuticals, Inc.2018-11-19
Superion® Indirect Decompression System (P140004/S010)Boston Scientific Neuromodulation2018-11-16
LCS(R) Total Knee System (P830055/S214)Depuy, Inc.2018-11-14
SUPARTZ FX/VISCO-3 (P980044/S049)Seikagaku Corp.2018-11-13
Infuse Bone Graft/medtronic Interbody Fusion Devise (P000058/S070)Medtronic Sofamor Danek USA, Inc.2018-11-09
Infuse Bone Graft (P000054/S051)Medtronic Sofamor Danek USA, Inc.2018-11-09
SpF Implantable Spinal Fusion Stimulators (P850035/S051)Ahp Eos Buyer, Inc.2018-11-02
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S062)Ahp Eos Buyer, Inc.2018-11-02
Synvisc and Synvisc-One (P940015/S041)Sanofi Genzyme Corp.2018-11-02
Oxford Partial Knee System (P010014/S082)Biomet Manufacturing Corp2018-10-24
LCS Total Knee System (P830055/S212)Depuy, Inc.2018-10-23
LCS Total Knee System (P830055/S209)Depuy, Inc.2018-10-22
Trident Alumina Insert (P000013/S015)Howmedica Osteonics Corp.2018-10-18
PRESTIGE LP Cervical Disc (P090029/S010)Medtronic Sofamor Danek USA, Inc.2018-09-27
LCS Total Knee System (P830055/S208)Depuy, Inc.2018-09-27
AUGMENT Bone Graft and AUGMENT Injectable (P100006/S006)Biomimetic Therapeutics, LLC2018-09-26
ATTUNE Revision Femoral Sleeves (P830055/S206)Depuy, Inc.2018-09-20
LCS Total Knee System (P830055/S207)Depuy, Inc.2018-09-11
ASCENSION MCP FINGER IMPLANT (P000057/S008)Smith & Nephew, Inc.2018-09-10
LCS Total Knee System (P830055/S203)Depuy, Inc.2018-08-31
INFUSE Bone Graft (P000054/S050)Medtronic Sofamor Danek USA, Inc.2018-08-29
INFUSE Bone Graft/LT-Cage Lumbar Tampered Fusion Device (P000058/S069)Medtronic Sofamor Danek USA, Inc.2018-08-29
Cartiva SCI reusable instrumentation (P150017/S007)Cartiva, Inc.2018-08-28
Superion® Indirect Decompression System (P140004/S015)Boston Scientific Neuromodulation2018-08-24
CERAMAX Ceramic Total Hip System (P070026/S055)DePuy Orthopaedics, Inc.2018-08-24
LCS Total Knee System (P830055/S205)Depuy, Inc.2018-08-24
PhysioStim, SpinalStim (P850007/S039)Orthofix, Inc.2018-08-22
CervicalStim (P030034/S012)Orthofix, Inc.2018-08-22
DUROLOANE (P170007/S001)Bioventus, LLC2018-08-17
SUPARTZ FX and VISCO-3 (P980044/S047)Seikagaku Corp.2018-08-16
activL Artificial Disc (P120024/S007)Highridge Medical, LLC2018-08-10
SUPARTZ FX and VISCO-3 (P980044/S048)Seikagaku Corp.2018-08-07
Gel-One (P080020/S030)Seikagaku Corp.2018-08-07
Oxford Partial Knee System (P010014/S080)Biomet Manufacturing Corp2018-07-27
Oxford Partial Knee System (P010014/S079)Biomet Manufacturing Corp2018-07-17
Oxford Partial Knee System (P010014/S071)Biomet Manufacturing Corp2018-07-03
Cartiva SCI (P150017/S009)Cartiva, Inc.2018-07-02
Cartiva SCI Implant (P150017/S008)Cartiva, Inc.2018-07-02
Ascension MCP (P000057/S010)Smith & Nephew, Inc.2018-06-29
LCS Total Knee System (P830055/S198)Depuy, Inc.2018-06-27
LCS Total Knee System (P830055/S202)Depuy, Inc.2018-06-25
ATTUNE Revision RP Tibial Base (P830055/S204)Depuy, Inc.2018-06-25
LCS Total Knee System: TRUMATCH Personalized Solutions (P830055/S197)Depuy, Inc.2018-06-22
Paradigm Spine Coflex Interlaminar Stabilization Device (P110008/S009)Companion Spine France2018-06-21
OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators (P910066/S029)Djo, LLC2018-06-19
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