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Orthopedic

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

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RecordFirmDate
GELSYN-3 (P110005/S007)Ibsa Institut Biochimique SA2020-12-28
LCS Total Knee System (P830055/S261)Depuy, Inc.2020-12-21
NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System (P060037/S069)Zimmer, Inc.2020-12-21
OPRA Implant System (P190009)Integrum AB2020-12-18
NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S070)Zimmer, Inc.2020-12-17
Mobi-C Cervical Disc Prosthesis Two Level (P110009/S026)Highridge Medical, LLC2020-12-15
Mobi-C Cervical Disc Prosthesis One Level (P110002/S026)Highridge Medical, LLC2020-12-15
ActaStim-S Spine Fusion Stimulator (P190030)Theragen, Inc.2020-12-09
Orthovisc (P030019/S025)Anika Therapeutics, Inc.2020-12-08
Oxford Partial Knee System (P010014/S100)Biomet Manufacturing Corp2020-12-07
LCS Total Knee System (P830055/S260)Depuy, Inc.2020-12-02
PRESTIGE LP Cervical Disc (P090029/S015)Medtronic Sofamor Danek USA, Inc.2020-12-01
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S015)Djo Global2020-12-01
CERAMAX Ceramic Total Hip System (P070026/S078)DePuy Orthopaedics, Inc.2020-11-30
DUROLANE (P170007/S007)Bioventus, LLC2020-11-29
LCS Total Knee System (P830055/S259)Depuy, Inc.2020-11-27
CERAMAX Ceramic Total Hip System (P070026/S077)DePuy Orthopaedics, Inc.2020-11-19
Gel-One (P080020/S040)Seikagaku Corp.2020-11-17
SUPARTZ FX, VISCO-3 (P980044/S054)Seikagaku Corp.2020-11-12
Gel-One (P080020/S039)Seikagaku Corp.2020-11-12
LCS Total Knee System (P830055/S258)Depuy, Inc.2020-11-10
Simplify Cervical Artificial Disc (P200022/S002)Nuvasive, Inc.2020-11-05
ATTUNE Total Knee System (P830055/S254)Depuy, Inc.2020-11-03
LCS Total Knee System (P830055/S257)Depuy, Inc.2020-10-21
DUROLANE (P170007/S008)Bioventus, LLC2020-10-21
M6-C Artificial Cervical Disc (P170036/S007)Spinal Kinetics, LLC2020-10-14
GELSYN-3 (P110005/S006)Ibsa Institut Biochimique SA2020-10-08
M6-C Artificial Cervical Disc (P170036/S006)Spinal Kinetics, LLC2020-10-08
DUROLANE (P170007/S006)Bioventus, LLC2020-10-08
GELSYN-3 (P110005/S005)Ibsa Institut Biochimique SA2020-10-08
CERAMAX Ceramic Total Hip System (P070026/S076)DePuy Orthopaedics, Inc.2020-10-05
Trident Ceramic System (P000013/S017)Howmedica Osteonics Corp.2020-09-30
LCS Total Knee System (P830055/S252)Depuy, Inc.2020-09-29
NexGen LPS-Flex and LPS Mobile Bearing Knee System (P060037/S068)Zimmer, Inc.2020-09-25
LCS Total Knee System (P830055/S256)Depuy, Inc.2020-09-25
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S067)Zimmer, Inc.2020-09-24
Simplify® Cervical Artificial Disc (P200022)Nuvasive, Inc.2020-09-18
Superion Indirect Decompression System (P140004/S022)Boston Scientific Neuromodulation2020-09-17
Superion Indirect Decompression System (P140004/S020)Boston Scientific Neuromodulation2020-09-16
Superion Indirect Decompression System (P140004/S024)Boston Scientific Neuromodulation2020-09-15
Superion Indirect Decompression System (P140004/S023)Boston Scientific Neuromodulation2020-09-09
Superion Indirect Decompression System (P140004/S021)Boston Scientific Neuromodulation2020-09-09
LCS Total Knee System (P830055/S255)Depuy, Inc.2020-09-08
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S082)Medtronic Sofamor Danek USA, Inc.2020-08-27
Infuse Bone Graft (P000054/S063)Medtronic Sofamor Danek USA, Inc.2020-08-27
R3 Biolox delta Ceramic Acetabular System (P150030/S008)Smith & Nephew, Inc.2020-08-21
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S014)Djo Global2020-08-20
Superion Indirect Decompression System (IDS) (P140004/S019)Boston Scientific Neuromodulation2020-08-14
activL Artifical Disc (P120024/S009)Highridge Medical, LLC2020-08-12
Superion Indirect Decompression (IDS) System (P140004/S018)Boston Scientific Neuromodulation2020-08-05
coflex® Interlaminar Technology (P110008/S012)Companion Spine France2020-08-05
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S066)Zimmer, Inc.2020-08-03
i-FACTOR Peptide Enhanced Bone Graft (P140019/S004)Cerapedics, LLC2020-07-22
Superion Indirect Decompression System (IDS) (P140004/S017)Boston Scientific Neuromodulation2020-07-22
CERAMAX Ceramic Total Hip System (P070026/S070)DePuy Orthopaedics, Inc.2020-07-21
LCS Total Knee System (P830055/S253)Depuy, Inc.2020-07-17
Gel-One (P080020/S038)Seikagaku Corp.2020-07-17
Cormet Hip Resurfacing System (P050016/S012)Corin USA2020-07-17
Synvisc, Synvisc-One (P940015/S046)Sanofi Genzyme Corp.2020-07-17
SUPARTZ FX and VISCO-3 (P980044/S053)Seikagaku Corp.2020-07-17
CERAMAX Ceramic Total Hip System (P070026/S075)DePuy Orthopaedics, Inc.2020-07-15
LCS Total Knee System (P830055/S249)Depuy, Inc.2020-07-14
LCS Total Knee System (P830055/S251)Depuy, Inc.2020-07-13
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S065)Zimmer, Inc.2020-07-13
GELSYN-3 (P110005/S004)Ibsa Institut Biochimique SA2020-07-10
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S078)Medtronic Sofamor Danek USA, Inc.2020-07-10
Infuse Bone Graft (P000054/S059)Medtronic Sofamor Danek USA, Inc.2020-07-10
CERAMAX Ceramic Total Hip System (P070026/S073)DePuy Orthopaedics, Inc.2020-07-08
LCS Total Knee System (P830055/S250)Depuy, Inc.2020-07-07
Ceramax Ceramic Total Hip System (P070026/S072)DePuy Orthopaedics, Inc.2020-06-26
CERAMAX Ceramic Total Hip System (P070026/S074)DePuy Orthopaedics, Inc.2020-06-24
NexGen LPS-Flex / LPS Mobile Bearing Knee System (P060037/S063)Zimmer, Inc.2020-06-18
LCS Total Knee System (P830055/S247)Depuy, Inc.2020-06-16
LCS Total Knee System (P830055/S248)Depuy, Inc.2020-06-15
TriVisc (P160057/S001)Channel-Markers Medical, LLC2020-06-07
GenVisc 850 (P140005/S004)Channel-Markers Medical, LLC2020-06-07
NexGen LPS-Flex and LPS-Mobile Bearing Knee (P060037/S064)Zimmer, Inc.2020-06-05
Barricaid Annular Closure Device (P160050/S006)Intrinsic Therapeutics2020-05-19
LCS® Total Knee System (P830055/S245)Depuy, Inc.2020-05-19
Barricaid Annular Closure Device (P160050/S005)Intrinsic Therapeutics2020-05-12
prodisc L Total Disc Replacement (P050010/S021)Centinel Spine, LLC2020-05-08
prodisc C Total Disc Replacement (P070001/S018)Centinel Spine, LLC2020-05-08
LCS Total Knee System (P830055/S244)Depuy, Inc.2020-04-30
LCS Total Knee System (P830055/S246)Depuy, Inc.2020-04-29
The Oxford Partial Knee System (P010014/S097)Biomet Manufacturing Corp2020-04-27
LCS Total Knee System (P830055/S243)Depuy, Inc.2020-04-22
CERAMAX Ceramic Total Hip System (P070026/S071)DePuy Orthopaedics, Inc.2020-04-22
Mobi-C Cervical Disc Prosthesis (One-Level Indication) (P110002/S024)Highridge Medical, LLC2020-04-16
EUFLEXXA (1% Sodium Hyaluronate) (P010029/S030)Ferring Pharmaceuticals, Inc.2020-04-16
Mobi-C Cervical Disc Prosthesis (Two-Level Indication) (P110009/S024)Highridge Medical, LLC2020-04-16
PRESTIGE LP Cervical Disc (P090029/S014)Medtronic Sofamor Danek USA, Inc.2020-04-15
prodisc L Total Disc Replacement (P050010/S020)Centinel Spine, LLC2020-04-10
coflex Interlaminar Stabilization Device (P110008/S011)Companion Spine France2020-04-07
Gel-One (P080020/S037)Seikagaku Corp.2020-03-31
SpinalStim (P850007/S044)Orthofix, Inc.2020-03-27
BRYAN Cervical Disc (P060023/S008)Companion Spine France Sas2020-03-18
Barricaid Anular Closure Device (ACD) (P160050/S003)Intrinsic Therapeutics2020-03-17
Gel-One (P080020/S036)Seikagaku Corp.2020-03-16
Prestiege LP Cervical Disc - Two-Level (P090029/S013)Medtronic Sofamor Danek USA, Inc.2020-03-06
M6-C Artificial Cervical Disc (P170036/S005)Spinal Kinetics, LLC2020-03-04
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