Atlas FDA

Orthopedic

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

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RecordFirmDate
TOPS™ System (P220002/S003)Premia Spine, Ltd.2023-10-27
LCS(R) TOTAL KNEE SYSTEM (P830055/S315)Depuy, Inc.2023-10-27
Prestige LP® Cervical Disc (P090029/S019)Medtronic Sofamor Danek USA, Inc.2023-10-26
Biomet EBI Bone Healing System (P790002/S039)Ahp Eos Buyer, Inc.2023-10-26
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System & Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator S (P850022/S033)Ahp Eos Buyer, Inc.2023-10-26
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S091)Medtronic Sofamor Danek USA, Inc.2023-10-06
INFUSE™ Bone Graft (P000054/S071)Medtronic Sofamor Danek USA, Inc.2023-10-06
CERAMAX Ceramic Total Hip System (P070026/S110)DePuy Orthopaedics, Inc.2023-10-05
LCS(R) Total Knee System (P830055/S314)Depuy, Inc.2023-09-28
Trident®, ABC® (P000013/S022)Howmedica Osteonics Corp.2023-09-27
LCS® Total Knee System (P830055/S312)Depuy, Inc.2023-09-15
TOPS™ System (P220002/S002)Premia Spine, Ltd.2023-09-07
Ceramic TRANSCEND® Hip Articulation System (P010001/S026)Ceramtec GmbH2023-09-06
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy (P850022/S032)Ahp Eos Buyer, Inc.2023-09-01
Infuse Bone Graft (P000058/S088)Medtronic Sofamor Danek USA, Inc.2023-08-25
Barricaid® Annular Closure Device (P160050/S007)Intrinsic Therapeutics2023-08-25
LCS Total Knee System (P830055/S308)Depuy, Inc.2023-08-22
INFUSE™ Bone Graft, Medtronic Interbody Fusion Device (P000058/S090)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft (P000054/S069)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft, Medtronic Interbody Fusion Device (P000058/S089)Medtronic Sofamor Danek USA, Inc.2023-08-21
INFUSE™ Bone Graft (P000054/S070)Medtronic Sofamor Danek USA, Inc.2023-08-21
i-FACTOR™ Peptide Enhanced Bone Graft (P140019/S009)Cerapedics, LLC2023-08-15
TOPS™ System (P220002/S001)Premia Spine, Ltd.2023-08-11
R3 DELTA CERAMIC HIP SYSTEM (P150030/S035)Smith & Nephew, Inc.2023-08-11
CERAMAX Ceramic Total Hip System (P070026/S107)DePuy Orthopaedics, Inc.2023-08-11
Monovisc (P090031/S016)Anika Therapeutics, Inc.2023-08-08
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S035)Highridge Medical, LLC2023-08-01
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S035)Highridge Medical, LLC2023-08-01
R3 Delta Ceramic Hip System (P150030/S031)Smith & Nephew, Inc.2023-07-28
R3 DELTA CERAMIC HIP SYSTEM (P150030/S034)Smith & Nephew, Inc.2023-07-11
EUFLEXXA (P010029/S035)Ferring Pharmaceuticals, Inc.2023-06-27
TriVisc® (P160057/S002)Channel-Markers Medical, LLC2023-06-22
GenVisc® 850 (P140005/S005)Channel-Markers Medical, LLC2023-06-22
CERAMAX Ceramic Total Hip System (P070026/S108)DePuy Orthopaedics, Inc.2023-06-22
R3 Delta Ceramic Hip System (P150030/S033)Smith & Nephew, Inc.2023-06-20
TOPS™ System (P220002)Premia Spine, Ltd.2023-06-15
M6-C Artificial Cervical Disc (P170036/S013)Spinal Kinetics, LLC2023-06-14
SECURE®-C Cervical Artificial Disc (P100003/S008)Globus Medical, Inc.2023-06-12
Simplify Disc (P200022/S011)Nuvasive, Inc.2023-06-09
Prestige LP® Cervical Disc (P090029/S017)Medtronic Sofamor Danek USA, Inc.2023-05-24
LCS® Total Knee System (P830055/S307)Depuy, Inc.2023-05-19
CERAMAX® Ceramic Total Hip System (P070026/S106)DePuy Orthopaedics, Inc.2023-05-19
EUFLEXXA (P010029/S034)Ferring Pharmaceuticals, Inc.2023-05-12
Superion Indirect Decompression System (IDS) (P140004/S030)Boston Scientific Neuromodulation2023-05-11
CERAMAX Ceramic Total Hip System (P070026/S105)DePuy Orthopaedics, Inc.2023-05-02
EUFLEXXA (P010029/S033)Ferring Pharmaceuticals, Inc.2023-04-26
i-FACTOR™ Peptide Enhanced Bone Graft (P140019/S008)Cerapedics, LLC2023-04-26
EUFLEXXA (P010029/S032)Ferring Pharmaceuticals, Inc.2023-04-25
OPRA™ System (P190009/S003)Integrum AB2023-04-21
Oxford Partial Knee (P010014/S104)Biomet Manufacturing Corp2023-04-06
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S083)Zimmer, Inc.2023-04-06
R3 DELTA CERAMIC HIP SYSTEM (P150030/S032)Smith & Nephew, Inc.2023-03-30
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S084)Zimmer, Inc.2023-03-24
ActaStim-S Non Invasive Spine Fusion Stimulator (P190030/S002)Theragen, Inc.2023-03-23
Simplify Cervical Artificial Disc (P200022/S010)Nuvasive, Inc.2023-03-15
GELSYN-3 (P110005/S013)Ibsa Institut Biochimique SA2023-03-10
Birmingham Hip Resurfacing (BHR) System (P040033/S037)Smith & Nephew, Inc.2023-02-22
R3 DELTA CERAMIC HIP SYSTEM (P150030/S029)Smith & Nephew, Inc.2023-02-12
R3 DELTA CERAMIC HIP SYSTEM (P150030/S030)Smith & Nephew, Inc.2023-02-12
LCS® Total Knee System (P830055/S304)Depuy, Inc.2023-02-09
CERAMAX® Ceramic Total Hip System (P070026/S104)DePuy Orthopaedics, Inc.2023-02-09
LCS® Total Knee System (P830055/S305)Depuy, Inc.2023-02-06
LCS® Total Knee System (P830055/S303)Depuy, Inc.2023-02-01
LCS(R) TOTAL KNEE SYSTEM (P830055/S302)Depuy, Inc.2023-01-30
TRILURON® (sodium hyaluronate) (P180040/S004)Fidia Farmaceutici S.P.A.2023-01-19
HYALGAN® (sodium hyaluronate) (P950027/S018)Fidia Farmaceutici S.P.A.2023-01-19
Synvisc, Synvisc-One (P940015/S051)Sanofi Genzyme Corp.2023-01-13
LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) (P110002/S033)Highridge Medical, LLC2023-01-12
LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level) (P110009/S033)Highridge Medical, LLC2023-01-12
Superion Indirect Decompression System (P140004/S029)Boston Scientific Neuromodulation2023-01-06
Gel-One (P080020/S051)Seikagaku Corp.2023-01-05
CERAMAX Ceramic Total Hip System (P070026/S103)DePuy Orthopaedics, Inc.2022-12-08
LCS® Total Knee System (P830055/S264)Depuy, Inc.2022-12-07
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S034)Highridge Medical, LLC2022-11-28
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S034)Highridge Medical, LLC2022-11-28
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator (P850022/S031)Ahp Eos Buyer, Inc.2022-11-23
SpF® Implantable Spinal Fusion Stimulators (P850035/S058)Ahp Eos Buyer, Inc.2022-11-23
Biomet® OrthoPak Non-invasive Bone Growth Stimulator System (P790002/S038)Ahp Eos Buyer, Inc.2022-11-23
EBI OsteoGen® Implantable Bone Growth Stimulators (P790005/S069)Ahp Eos Buyer, Inc.2022-11-23
STAR PSI System (P050050/S023)Djo Global2022-11-22
R3™ DELTA CERAMIC ACETABULAR SYSTEM (P150030/S028)Smith & Nephew, Inc.2022-11-18
i-FACTOR® Peptide Enhanced Bone Graft (P140019/S007)Cerapedics, LLC2022-11-15
LCS® Knee System (P830055/S300)Depuy, Inc.2022-11-14
LCS® Knee System (P830055/S301)Depuy, Inc.2022-11-10
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S032)Highridge Medical, LLC2022-11-09
LDR Spine Mobi-C Cervical Disc Prosthesis (P110002/S032)Highridge Medical, LLC2022-11-09
Monovisc High Molecular Weight Hyaluronan (P090031/S015)Anika Therapeutics, Inc.2022-11-08
Orthovisc, Sodium Hyaluronic (P030019/S027)Anika Therapeutics, Inc.2022-11-08
Monovisc High Molecular Weight Hyaluronan (P090031/S014)Anika Therapeutics, Inc.2022-11-04
Synvisc and Synvisc-One (P940015/S050)Sanofi Genzyme Corp.2022-11-04
Simplify Cervical Artificial Disc (P200022/S009)Nuvasive, Inc.2022-11-02
M6-C Artificial Cervical Disc (P170036/S012)Spinal Kinetics, LLC2022-11-01
LCS® Total Knee System (P830055/S298)Depuy, Inc.2022-10-27
Oxford® Partial Knee System (P010014/S103)Biomet Manufacturing Corp2022-10-25
Gel-One (P080020/S049)Seikagaku Corp.2022-10-19
DUROLANE (P170007/S014)Bioventus, LLC2022-10-14
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S081)Zimmer, Inc.2022-10-14
LCS® Total Knee System (P830055/S299)Depuy, Inc.2022-10-07
GELSYN-3 (P110005/S012)Ibsa Institut Biochimique SA2022-10-07
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S082)Zimmer, Inc.2022-10-06
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