Atlas FDA

Orthopedic

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

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RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
DUROLANE (P170007/S015)Bioventus, LLC2025-12-23
SYNOJOYNT™ (P170016/S001)Mesoblast2025-12-23
SUPARTZ FX; VISCO-3 (P980044/S065)Seikagaku Corp.2025-12-19
Barricaid® Annular Closure Device (P160050/S011)Intrinsic Therapeutics2025-12-18
ATTUNE™ Revision Rotating Platform (RP) Knee System (P830055/S346)Depuy, Inc.2025-12-18
TOUCH® CMC 1 Prosthesis (P240020/S003)Keri Medical SA2025-12-17
LCS Total Knee System (P830055/S355)Depuy, Inc.2025-12-15
PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) (P240001/S001)Cerapedics, Inc.2025-12-11
LCS® Total Knee System (P830055/S354)Depuy, Inc.2025-12-11
DIAM­™ Spinal Stabilization System (P240043)Companion Spine France Sas2025-12-10
LCS® Total Knee System (P830055/S353)Depuy, Inc.2025-12-09
Ceramax Ceramic Hip System (P070026/S123)DePuy Orthopaedics, Inc.2025-12-09
LCS® Total Knee System (P830055/S352)Depuy, Inc.2025-11-26
OPRA Implant System, Abutment component (P190009/S006)Integrum AB2025-11-20
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S037)Highridge Medical, LLC2025-10-29
TOPS™ System (P220002/S010)Premia Spine, Ltd.2025-10-29
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S037)Highridge Medical, LLC2025-10-29
EUFLEXXA® (1% SODIUM HYALURONATE) (P010029/S042)Ferring Pharmaceuticals, Inc.2025-10-16
prodisc C SK and prodisc C Vivo (P070001/S025)Centinel Spine, LLC2025-10-10
Barricaid® Annular Closure Device (P160050/S010)Intrinsic Therapeutics2025-10-09
LCS® Total Knee System (P830055/S350)Depuy, Inc.2025-09-26
Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027)Howmedica Osteonics Corp.2025-09-17
LCS® Total Knee System (P830055/S349)Depuy, Inc.2025-09-09
TOUCH® CMC 1 Prosthesis (P240020/S001)Keri Medical SA2025-09-05
TOUCH® CMC 1 Prosthesis (P240020/S002)Keri Medical SA2025-09-05
PRODISC L (P050010/S027)Centinel Spine, LLC2025-09-02
LCS Total Knee System (P830055/S348)Depuy, Inc.2025-08-29
SUPARTZ FX (P980044/S064)Seikagaku Corp.2025-08-18
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
OPRA™ Implant System (P190009/S009)Integrum AB2025-08-14
Oxford™ Knee System (P010014/S111)Biomet Manufacturing Corp2025-08-07
Oxford Partial Knee System (P010014/S109)Biomet Manufacturing Corp2025-08-07
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)DePuy Orthopaedics, Inc.2025-08-05
LCS® Total Knee System (P830055/S347)Depuy, Inc.2025-08-05
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)DePuy Orthopaedics, Inc.2025-08-01
prodisc L (P050010/S028)Centinel Spine, LLC2025-07-30
prodisc® C (P070001/S029)Centinel Spine, LLC2025-07-30
SUPARTZ FX; VISCO-3 (P980044/S063)Seikagaku Corp.2025-07-22
LCS(R) TOTAL KNEE SYSTEM (P830055/S341)Depuy, Inc.2025-07-18
TOUCH® CMC 1 Prosthesis (P240020)Keri Medical SA2025-07-10
CERAMAX® ceramic total hip system (P070026/S120)DePuy Orthopaedics, Inc.2025-06-24
LCS® Total Knee System (P830055/S345)Depuy, Inc.2025-06-24
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110)Biomet Manufacturing Corp2025-06-24
Transcend® Hip Articulation System (P010001/S031)Ceramtec GmbH2025-06-20
PearlMatrix™ Bone Graft (P240001)Cerapedics, Inc.2025-06-18
Gel-One (P080020/S054)Seikagaku Corp.2025-06-18
Simplify® Cervical Artificial Disc (P200022/S016)Nuvasive, Inc.2025-06-05
Ceramic TRANSCEND® Hip Articulation System (P010001/S030)Ceramtec GmbH2025-06-05
PRODISC -L TOTAL DISC REPLACEMENT DEVICE (P050010/S025)Centinel Spine, LLC2025-06-04
prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK (P070001/S028)Centinel Spine, LLC2025-06-04
Simplify® Cervical Artificial Disc (P200022/S017)Nuvasive, Inc.2025-05-29
TOPS™ System (P220002/S008)Premia Spine, Ltd.2025-05-29
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S041)Ferring Pharmaceuticals, Inc.2025-05-28
Trident Acetabular System: Trident Alumina Inserts (P000013/S026)Howmedica Osteonics Corp.2025-05-23
LCS® Total Knee System - MBT Thick Tray (P830055/S344)Depuy, Inc.2025-05-21
GenVisc 850 (P140005/S006)Channel-Markers Medical, LLC2025-05-20
TriVisc (P160057/S003)Channel-Markers Medical, LLC2025-05-20
LCS Total Knee System (P830055/S343)Depuy, Inc.2025-05-02
Ceramic TRANSCEND® Hip Articulation System (P010001/S029)Ceramtec GmbH2025-04-23
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
LCS(R) TOTAL KNEE SYSTEM (P830055/S342)Depuy, Inc.2025-04-10
HYMOVIS ONE (P150010/S005)Fidia Farmaceutici2025-04-09
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S119)DePuy Orthopaedics, Inc.2025-04-04
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
TOPS™ System (P220002/S006)Premia Spine, Ltd.2025-03-25
TOPS™ System (P220002/S007)Premia Spine, Ltd.2025-03-21
AccelStim (P210035/S003)Orthofix US, LLC2025-03-21
DePuy Ceramax Ceramic Total Hip System (P070026/S114)DePuy Orthopaedics, Inc.2025-03-19
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094)Medtronic Sofamor Danek USA, Inc.2025-03-19
INFUSE® Bone Graft (P000054/S074)Medtronic Sofamor Danek USA, Inc.2025-03-19
LCS® Total Knee System (P830055/S340)Depuy, Inc.2025-03-19
ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET (P830055/S325)Depuy, Inc.2025-03-13
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
Ceramax Ceramic Hip System (P070026/S117)DePuy Orthopaedics, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
LCS® Total Knee System (P830055/S338)Depuy, Inc.2025-02-21
LCS® Total Knee System (P830055/S339)Depuy, Inc.2025-02-20
Attune Primary System (P830055/S334)Depuy, Inc.2025-02-20
Simplify Disc (P200022/S012)Nuvasive, Inc.2025-02-18
LCS® Total Knee System (P830055/S337)Depuy, Inc.2025-02-13
Simplify Cervical Artificial Disc (P200022/S015)Nuvasive, Inc.2025-02-13
Ceramax® Ceramic Total Hip System (P070026/S116)DePuy Orthopaedics, Inc.2025-02-11
i-FACTOR™ Peptide Enhanced Bone Graft (P140019/S012)Cerapedics, LLC2025-02-06
prodisc® L (P050010/S026)Centinel Spine, LLC2025-01-17
ManaFuse (P210016)Enovis2025-01-17
TOPS System (P220002/S005)Premia Spine, Ltd.2025-01-17
Gel-One (P080020/S053)Seikagaku Corp.2025-01-17
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
OPRA™ Implant System (P190009/S007)Integrum AB2025-01-15
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10
Synvisc, Synvisc-One (P940015/S052)Sanofi Genzyme Corp.2025-01-02
Simplify Cervical Artificial Disc (P200022/S014)Nuvasive, Inc.2024-12-18
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
LDR Spine Mobi-C Cervical Disc Prosthesis (P110009/S036)Highridge Medical, LLC2024-12-02
LDR Spine Mobi-C Cervical Disc Prosthesis (P110002/S036)Highridge Medical, LLC2024-12-02
Oxford® Partial Knee System (P010014/S107)Biomet Manufacturing Corp2024-11-22
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