Atlas FDA

Orthopedic

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

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RecordFirmDate
HYALGAN® (P950027/S017)Fidia Farmaceutici S.P.A.2022-10-04
CERAMAX® Ceramic Total Hip System (P070026/S102)DePuy Orthopaedics, Inc.2022-10-04
LCS® Total Knee System (P830055/S296)Depuy, Inc.2022-10-04
LCS® Total Knee System (P830055/S297)Depuy, Inc.2022-10-04
TRILURON® (P180040/S003)Fidia Farmaceutici S.P.A.2022-10-04
R3 DELTA CERAMIC ACETABULAR SYSTEM (P150030/S027)Smith & Nephew, Inc.2022-09-29
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S025)Djo Global2022-09-29
R3 Delta Ceramic Acetabular System (P150030/S026)Smith & Nephew, Inc.2022-09-21
R3 Delta Ceramic Acetabular System (P150030/S025)Smith & Nephew, Inc.2022-09-13
R3TM delta Ceramic Acetabular System (P150030/S014)Smith & Nephew, Inc.2022-09-09
LCS Total Knee System (P830055/S295)Depuy, Inc.2022-09-01
R3 Delta Ceramic Hip System (P150030/S024)Smith & Nephew, Inc.2022-09-01
CERAMAX® Ceramic Total Hip System (P070026/S101)DePuy Orthopaedics, Inc.2022-08-26
SpF Implantable Spinal Fusion Stimulators (P850035/S057)Ahp Eos Buyer, Inc.2022-08-25
EBI OsteoGen™ Implantable Bone Growth Stimulators (P790005/S068)Ahp Eos Buyer, Inc.2022-08-25
LCS Total Knee System (P830055/S294)Depuy, Inc.2022-08-15
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S080)Zimmer, Inc.2022-08-15
LCS(R) Total Knee System (P830055/S293)Depuy, Inc.2022-08-11
CERAMAX® Ceramic Total Hip System (P070026/S086)DePuy Orthopaedics, Inc.2022-08-10
Infuse™ Bone Graft/Medtronic Interbody Fusion Device (P000058/S087)Medtronic Sofamor Danek USA, Inc.2022-08-09
Infuse™ Bone Graft (P000054/S068)Medtronic Sofamor Danek USA, Inc.2022-08-09
HYMOVIS® (P150010/S002)Fidia Farmaceutici2022-08-08
R3TM Delta Ceramic Acetabular System (P150030/S023)Smith & Nephew, Inc.2022-08-08
TRILURON® (P180040/S002)Fidia Farmaceutici S.P.A.2022-08-08
Reflection Ceramic Hip System (P030022/S049)Smith & Nephew, Inc.2022-08-08
HYALGAN® (P950027/S016)Fidia Farmaceutici S.P.A.2022-08-08
CERAMAX Ceramic Total Hip System (P070026/S095)DePuy Orthopaedics, Inc.2022-07-25
LCS(R) Total Knee System (P830055/S286)Depuy, Inc.2022-07-25
Gel-One (P080020/S048)Seikagaku Corp.2022-07-22
Transcend® Hip Articulation System (P010001/S025)Ceramtec GmbH2022-07-20
Oxford Partial Knee System (P010014/S102)Biomet Manufacturing Corp2022-07-14
Monovisc High Molecular Weight Hyaluronan (P090031/S013)Anika Therapeutics, Inc.2022-07-13
CERAMAX® Ceramic Total Hip System (P070026/S100)DePuy Orthopaedics, Inc.2022-07-12
prodisc C: prodisc C SK, prodisc C Nova, prodisc C Vivo (P070001/S019)Centinel Spine, LLC2022-07-07
LCS Total Knee System (P830055/S292)Depuy, Inc.2022-07-06
LCS Total Knee System (P830055/S277)Depuy, Inc.2022-07-06
Reflection Ceramic Acetabular Hip System (P030022/S048)Smith & Nephew, Inc.2022-07-05
M6-C Artificial Cervical Disc (P170036/S011)Spinal Kinetics, LLC2022-07-01
LCS Total Knee System (P830055/S289)Depuy, Inc.2022-06-29
activL Artificial Disc (P120024/S012)Highridge Medical, LLC2022-06-24
Reflection Ceramic Hip System (P030022/S047)Smith & Nephew, Inc.2022-06-21
R3 Delta Ceramic Acetabular System (P150030/S022)Smith & Nephew, Inc.2022-06-21
ActaStim-S Spine Fusion Stimulator (P190030/S001)Theragen, Inc.2022-06-17
CervicalStim® (P030034/S017)Orthofix, Inc.2022-06-14
PhysioStim®, SpinalStim® (P850007/S046)Orthofix, Inc.2022-06-14
Augment® Bone Graft (P100006/S013)Biomimetic Therapeutics, LLC2022-06-13
Infuse Bone Graft (P000054/S067)Medtronic Sofamor Danek USA, Inc.2022-06-09
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S086)Medtronic Sofamor Danek USA, Inc.2022-06-08
Ceramax Ceramic Total Hip System (P070026/S098)DePuy Orthopaedics, Inc.2022-06-07
NexGen LPS-Flex/ LPS-Mobile Bearing Knee (P060037/S079)Zimmer, Inc.2022-05-20
Birmingham Hip Resurfacing (BHR) System (P040033/S036)Smith & Nephew, Inc.2022-05-19
R3 Delta Ceramic Hip System, Reflection Ceramic Hip System (P150030/S021)Smith & Nephew, Inc.2022-05-17
LCS Total Knee System (P830055/S287)Depuy, Inc.2022-05-13
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) (P050050/S021)Djo Global2022-05-06
CERAMAX® Ceramic Total Hip System (P070026/S097)DePuy Orthopaedics, Inc.2022-05-05
R3™ Delta Ceramic Acetabular System (P150030/S020)Smith & Nephew, Inc.2022-05-03
AccelStimTM Bone Growth Stimulator (P210035)Orthofix US, LLC2022-05-03
LCS Total Knee System (P830055/S288)Depuy, Inc.2022-04-27
CERAMAX Ceramic Total Hip System (P070026/S096)DePuy Orthopaedics, Inc.2022-04-14
M6-C Artificial Cervical Disc (P170036/S010)Spinal Kinetics, LLC2022-04-05
Oxford Partial Knee System (P010014/S101)Biomet Manufacturing Corp2022-04-04
Trident Acetabular System: Trident Alumina Inserts (P000013/S020)Howmedica Osteonics Corp.2022-04-01
R3 Delta Ceramic Hip System (P150030/S019)Smith & Nephew, Inc.2022-04-01
Suparts FX & Visco-3 (P980044/S059)Seikagaku Corp.2022-03-31
GEL-ONE (P080020/S047)Seikagaku Corp.2022-03-31
Agili-C (P210034)Smith and Nephew, Inc.2022-03-29
LCS(R) Total Knee System (P830055/S285)Depuy, Inc.2022-03-29
LCS® Total Knee System (P830055/S284)Depuy, Inc.2022-03-24
NexGen LPS-Flex/ LPS-Mobile Bearing Knee System (P060037/S078)Zimmer, Inc.2022-03-23
Ceramax® Ceramic Total Hip System (P070026/S094)DePuy Orthopaedics, Inc.2022-03-22
GELSYN-3 (P110005/S011)Ibsa Institut Biochimique SA2022-03-18
Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S022)Djo Global2022-03-11
CERAMAX Total Hip System (P070026/S093)DePuy Orthopaedics, Inc.2022-03-10
LCS Total Knee System (P830055/S282)Depuy, Inc.2022-03-08
CERAMAX Ceramic Total Hip System (P070026/S079)DePuy Orthopaedics, Inc.2022-03-05
R3TM delta Ceramic Acetabular System (P150030/S016)Smith & Nephew, Inc.2022-03-04
Durolane (P170007/S013)Bioventus, LLC2022-03-03
Vertiflex Instrument Platform (VIP) Kit (P140004/S028)Boston Scientific Neuromodulation2022-03-02
DUROLANE (P170007/S012)Bioventus, LLC2022-03-02
Trident(R) Acetabular System (P000013/S019)Howmedica Osteonics Corp.2022-03-01
LCS® Total Knee System (P830055/S280)Depuy, Inc.2022-02-24
CERAMAX® Ceramic Total Hip System (P070026/S091)DePuy Orthopaedics, Inc.2022-02-22
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S081)Medtronic Sofamor Danek USA, Inc.2022-02-18
LCS® Total Knee System (P830055/S281)Depuy, Inc.2022-02-18
Infuse Bone Graft (P000054/S062)Medtronic Sofamor Danek USA, Inc.2022-02-18
INFUSE™ BoneGraft/Medtronic lnterbody Fusion Device (P000058/S085)Medtronic Sofamor Danek USA, Inc.2022-02-17
INFUSE™ Bone Graft (P000054/S066)Medtronic Sofamor Danek USA, Inc.2022-02-17
i-FACTOR Peptide Enhanced Bone Graft (P140019/S006)Cerapedics, LLC2022-02-16
CERAMAX Ceramic Total Hip System (P070026/S090)DePuy Orthopaedics, Inc.2022-02-14
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S077)Zimmer, Inc.2022-02-10
Simplify® Cervical Artificial Disc (P200022/S008)Nuvasive, Inc.2022-02-09
Superion Indirect Decompression System (P140004/S027)Boston Scientific Neuromodulation2022-02-08
DUROLANE (P170007/S011)Bioventus, LLC2022-01-25
CERAMAX Ceramic Total Hip System (P070026/S089)DePuy Orthopaedics, Inc.2022-01-21
LCS Total Knee System (P830055/S279)Depuy, Inc.2022-01-20
LCS® Total Knee System (P830055/S278)Depuy, Inc.2022-01-19
i-FACTOR™ Peptide Enhanced Bone Graft (P140019/S005)Cerapedics, LLC2022-01-07
Exogen (P900009/S048)Bioventus, LLC2022-01-07
NexGen® LPS-Flex / LPS-Mobile Bearing Knee (P060037/S076)Zimmer, Inc.2022-01-05
DUROLANE (P170007/S010)Bioventus, LLC2021-12-22
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