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Orthopedic

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

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RecordFirmDate
AUGMENT INJECTABLE (P100006/S005)Biomimetic Therapeutics, LLC2018-06-12
Supartz FX, Visco-3 (P980044/S046)Seikagaku Corp.2018-06-08
Oxford Partial Knee System (P010014/S077)Biomet Manufacturing Corp2018-06-01
Mobi-C Cervical Disc Prosthesis (P110009/S020)Highridge Medical, LLC2018-05-30
Mobi-C Cervical Disc Prosthesis (P110002/S020)Highridge Medical, LLC2018-05-30
Attune Revision Tibial Augments (P830055/S200)Depuy, Inc.2018-05-29
Supartz FX, Visco-3 (P980044/S045)Seikagaku Corp.2018-05-25
NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S056)Zimmer, Inc.2018-05-23
EXOGEN Ultrasound Bone Healing System (P900009/S043)Bioventus, LLC2018-05-22
LCS(R) Total Knee System (P830055/S201)Depuy, Inc.2018-05-22
LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) (P110009/S021)Highridge Medical, LLC2018-05-15
LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) (P110002/S021)Highridge Medical, LLC2018-05-15
SYNOJOYNT (P170016)Mesoblast2018-05-08
GELSYN-3 (P110005/S003)Ibsa Institut Biochimique SA2018-05-07
SpF Implantable Spinal Fusion Stimulators (P850035/S053)Ahp Eos Buyer, Inc.2018-05-07
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S064)Ahp Eos Buyer, Inc.2018-05-07
EBI OsteoGen Impantable Bone Growth Stimulators (P790005/S063)Ahp Eos Buyer, Inc.2018-05-04
Oxford Partial Knee System (P010014/S075)Biomet Manufacturing Corp2018-05-04
SpF Implantable Spinal Fusion Stimulators (P850035/S052)Ahp Eos Buyer, Inc.2018-05-04
Ceramic Total Hip System (P070026/S053)DePuy Orthopaedics, Inc.2018-05-02
LCS Total Knee System (P830055/S199)Depuy, Inc.2018-05-02
Ceramax Ceramic Total Hip System (P070026/S054)DePuy Orthopaedics, Inc.2018-05-02
Euflexxa (1% Sodium Hyaluronate) (P010029/S026)Ferring Pharmaceuticals, Inc.2018-04-26
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S061)Ahp Eos Buyer, Inc.2018-04-26
SpF Implantable Spinal Fusion Stimulators (P850035/S050)Ahp Eos Buyer, Inc.2018-04-26
coflex® Interlaminar Technology (P110008/S008)Companion Spine France2018-04-25
LCS Total Knee System (P830055/S196)Depuy, Inc.2018-04-23
Transcend Hip Articulation System (P010001/S018)Ceramtec GmbH2018-04-20
COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S010)Companion Spine France2018-04-20
Superion® Indirect Decompression System (P140004/S013)Boston Scientific Neuromodulation2018-04-19
Oxford Patrial Knee System (P010014/S073)Biomet Manufacturing Corp2018-04-19
Oxford Partial Knee System (P010014/S072)Biomet Manufacturing Corp2018-04-13
Oxford Partial Knee System (P010014/S074)Biomet Manufacturing Corp2018-04-11
Superion Indirect Decompression System (P140004/S011)Boston Scientific Neuromodulation2018-04-09
SpF Implantable Spinal Fusion Stimulators (P850035/S048)Ahp Eos Buyer, Inc.2018-03-30
Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System (P850022/S029)Ahp Eos Buyer, Inc.2018-03-30
Biomet EBI Bone Healing System (P790002/S037)Ahp Eos Buyer, Inc.2018-03-30
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S059)Ahp Eos Buyer, Inc.2018-03-30
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S060)Ahp Eos Buyer, Inc.2018-03-29
NexGen LPS-Flex / LPS Mobile Bearing Knee System (P060037/S055)Zimmer, Inc.2018-03-29
SpF Implantable Spinal Fusion Stimulators (P850035/S049)Ahp Eos Buyer, Inc.2018-03-29
Ceramax Ceramic Total Hip System (P070026/S052)DePuy Orthopaedics, Inc.2018-03-26
Superion Indirect Decompression System (P140004/S012)Boston Scientific Neuromodulation2018-03-26
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S039)Smith & Nephew, Inc.2018-03-20
GEL-ONE (P080020/S026)Seikagaku Corp.2018-03-15
SUPARTZ FX and VISCO-3 (P980044/S039)Seikagaku Corp.2018-03-15
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S058)Ahp Eos Buyer, Inc.2018-03-14
SpF Implantable Spinal Fusion Stimulators (P850035/S046)Ahp Eos Buyer, Inc.2018-03-14
Supartz FX and Visco-3 (P980044/S043)Seikagaku Corp.2018-03-14
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S057)Ahp Eos Buyer, Inc.2018-03-14
Gel-One (P080020/S029)Seikagaku Corp.2018-03-14
SPF Implantable Spinal Fusion Stimulators (P850035/S047)Ahp Eos Buyer, Inc.2018-03-14
CervicalStim (P030034/S011)Orthofix, Inc.2018-03-07
PhysioStim and SpinalStim (P850007/S038)Orthofix, Inc.2018-03-07
ATTUNE Revision RP Tibia Base/LCS Total Knee System (P830055/S195)Depuy, Inc.2018-03-07
Oxford Partial Knee System (P010014/S070)Biomet Manufacturing Corp2018-03-05
NexGen LPS-Flex / LPS-Mobile Bearing Knee (P060037/S054)Zimmer, Inc.2018-03-05
LCS Total Knee System (P830055/S194)Depuy, Inc.2018-03-02
Birmingham Hip Resurfacing (BHR) System (P040033/S033)Smith & Nephew, Inc.2018-03-02
Ceramic Total Hip System (P070026/S051)DePuy Orthopaedics, Inc.2018-03-02
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S031)Smith & Nephew, Inc.2018-02-22
Oxford Partial Knee System (P010014/S069)Biomet Manufacturing Corp2018-02-22
Superion Indirect Decompression System (P140004/S009)Boston Scientific Neuromodulation2018-02-22
Ceramic Transcend® Hip Articulation System (P030027/S005)Microport Orthopedics, Inc.2018-02-16
PRESTIGE LP Cervical Disc (P090029/S009)Medtronic Sofamor Danek USA, Inc.2018-02-13
Gel-One (P080020/S028)Seikagaku Corp.2018-02-09
SUPARTZ FX and VISCO-3 (P980044/S042)Seikagaku Corp.2018-02-09
BRYAN (TM) CERVICAL DISC (P060023/S006)Companion Spine France Sas2018-01-31
PRESTIGE: LP(TM) CERVICAL DISC (P090029/S008)Medtronic Sofamor Danek USA, Inc.2018-01-31
S.T.A.R. Ankle System (P050050/S011)Djo Global2018-01-08
SUPERION INDIRECT DECOMPRESSION SYSTEM (P140004/S006)Boston Scientific Neuromodulation2017-12-28
EUFLEXXA (1% Sodium Hyaluronate) (P010029/S025)Ferring Pharmaceuticals, Inc.2017-12-28
LCS Total Knee System Trumatch Personalized Solutions Surgical Technique with Attune Knee System Intuition Solo Instrume (P830055/S192)Depuy, Inc.2017-12-22
Birmingham Hip Resurfacing System (P040033/S032)Smith & Nephew, Inc.2017-12-20
REFLECTION Ceramic Acetabular Hip System (P030022/S045)Smith & Nephew, Inc.2017-12-20
R3 DELTA Ceramic Hip System (P150030/S004)Smith & Nephew, Inc.2017-12-20
Gel-One (P080020/S027)Seikagaku Corp.2017-12-14
Ceramax Ceramic Total Hip System (P070026/S050)DePuy Orthopaedics, Inc.2017-12-14
SUPARTZ FX / VISCO-3 (P980044/S041)Seikagaku Corp.2017-12-14
INFUSE Bone Graft / LT-Cage Lumbar Tapered Fusion Device (P000058/S068)Medtronic Sofamor Danek USA, Inc.2017-12-13
Infuse Bone Graft (P000054/S049)Medtronic Sofamor Danek USA, Inc.2017-12-13
Oxford Partial Knee System - Femoral and Tibial Tray Components (P010014/S068)Biomet Manufacturing Corp2017-12-13
R3 Delta Ceramic Acetabular System (P150030/S003)Smith & Nephew, Inc.2017-11-30
LCS Total Knee System (P830055/S193)Depuy, Inc.2017-11-27
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S053)Zimmer, Inc.2017-11-15
ProDisc-L Total Disc Replacement (P050010/S019)Centinel Spine, LLC2017-11-15
TRIVISC (P160057)Channel-Markers Medical, LLC2017-11-13
Cartiva Synthetic Cartilage Implant (P150017/S006)Cartiva, Inc.2017-11-09
CERAMAX® Ceramic Total Hip System (P070026/S046)DePuy Orthopaedics, Inc.2017-11-08
LCS Total Knee System (P830055/S188)Depuy, Inc.2017-11-06
Physio-Stim (P850007/S037)Orthofix, Inc.2017-10-31
ProDisc-C Total Disc Replacement (P070001/S016)Centinel Spine, LLC2017-10-20
LPS-Flex Mobile and LPS Mobioe Bearing Knee System (P060037/S052)Zimmer, Inc.2017-10-19
LCS Total Knee System (P830055/S191)Depuy, Inc.2017-10-19
LCS Total Knee System (P830055/S189)Depuy, Inc.2017-10-18
LCS Total Knee System (P830055/S190)Depuy, Inc.2017-10-18
Oxford Partial Knee System (P010014/S066)Biomet Manufacturing Corp2017-10-06
Oxford Partial Knee System - tibial tray and femoral components (P010014/S067)Biomet Manufacturing Corp2017-10-05
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S051)Zimmer, Inc.2017-10-05
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S050)Zimmer, Inc.2017-09-29
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