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Orthopedic

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

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RecordFirmDate
LCS TOTAL KNEE SYSTEM (P830055/S179)Depuy, Inc.2017-09-28
Infuse (R) Bone Graft (P000058/S065)Medtronic Sofamor Danek USA, Inc.2017-09-21
LCS Total Knee System (P830055/S187)Depuy, Inc.2017-09-20
LCS(R) Total Knee System (P830055/S186)Depuy, Inc.2017-09-18
ATTUNE Revision Knee System (P830055/S184)Depuy, Inc.2017-09-18
LCS(R) TOTAL KNEE SYSTEM (P830055/S183)Depuy, Inc.2017-09-12
EXOGEN Ultrasound Bone Healing System (P900009/S042)Bioventus, LLC2017-09-11
Oxford Partial Knee System - Femoral Components, Tibial Tray Components, Meniscal Bearings (P010014/S065)Biomet Manufacturing Corp2017-09-08
DUROLANE (P170007)Bioventus, LLC2017-08-29
MONOVISC High Molecular Weight Hyaluronan (P090031/S008)Anika Therapeutics, Inc.2017-08-21
CERAMAX Ceramic Total Hip System (P070026/S040)DePuy Orthopaedics, Inc.2017-08-18
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007)Globus Medical, Inc.2017-08-18
RCHS Ceramic Liners and Shells (P030022/S044)Smith & Nephew, Inc.2017-08-17
ASCENSION MCP (P000057/S009)Smith & Nephew, Inc.2017-08-04
SUPARTZ FX and VISCO-3 (P980044/S040)Seikagaku Corp.2017-07-28
PRODISC-C TOTAL DISC REPLACEMENT (P070001/S015)Centinel Spine, LLC2017-07-27
LCS Total Knee System (P830055/S185)Depuy, Inc.2017-07-25
CERAMAX CERAMIC HIP SYSTEM (P070026/S049)DePuy Orthopaedics, Inc.2017-07-24
Ceramax Ceramic Total Hip System (P070026/S048)DePuy Orthopaedics, Inc.2017-07-13
Oxford Partial Knee System (P010014/S063)Biomet Manufacturing Corp2017-07-07
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S049)Zimmer, Inc.2017-07-06
SpinalStim (P850007/S036)Orthofix, Inc.2017-06-22
CervicalStim (P030034/S010)Orthofix, Inc.2017-06-22
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S067)Medtronic Sofamor Danek USA, Inc.2017-06-21
Infuse Bone Graft (P000054/S048)Medtronic Sofamor Danek USA, Inc.2017-06-21
ACTIVL ARTIFICIAL DISC (P120024/S004)Highridge Medical, LLC2017-06-20
LCS(R) Total Knee System (P830055/S182)Depuy, Inc.2017-06-08
Superion Indirect Decompression System (P140004/S008)Boston Scientific Neuromodulation2017-06-07
REFLECTION Ceramic Acetabular Hip System (RCHS) (P030022/S043)Smith & Nephew, Inc.2017-06-02
MOBI-C Cervical Disc Prosthesis (P110009/S019)Highridge Medical, LLC2017-06-02
R3 DELTA Ceramic Hip System (P150030/S002)Smith & Nephew, Inc.2017-06-02
SpF Implantable Spinal Fusion Stimulators (P850035/S045)Ahp Eos Buyer, Inc.2017-06-02
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S056)Ahp Eos Buyer, Inc.2017-06-02
MOBI-C Cervical Disc Prosthesis (P110002/S019)Highridge Medical, LLC2017-06-02
Mobi-C Cervical Disc Prosthesis for use at One or Two Levels (P110009/S018)Highridge Medical, LLC2017-05-23
MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S018)Highridge Medical, LLC2017-05-23
Oxford Partial Knee System- Meniscal bearings (P010014/S062)Biomet Manufacturing Corp2017-05-16
SYNVISC ONE (P940015/S040)Sanofi Genzyme Corp.2017-05-11
MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) (P110002/S015)Highridge Medical, LLC2017-05-05
MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) (P110009/S015)Highridge Medical, LLC2017-05-05
Aesculap Implant Systems (P120024/S005)Highridge Medical, LLC2017-04-26
LCS Total Knee System (P830055/S181)Depuy, Inc.2017-04-20
PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS (P090029/S007)Medtronic Sofamor Danek USA, Inc.2017-04-03
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021)Exactech, Inc.2017-04-03
Supartz FX and Visco-3 (P980044/S038)Seikagaku Corp.2017-03-29
Synvisc (P940015/S039)Sanofi Genzyme Corp.2017-03-29
CERAMAX® Ceramic Total Hip System (P070026/S047)DePuy Orthopaedics, Inc.2017-03-28
SpF Implantable Spinal Fusion Stimulators (P850035/S044)Ahp Eos Buyer, Inc.2017-03-27
EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S055)Ahp Eos Buyer, Inc.2017-03-27
Superion® Indirect Decompression System (IDS) (P140004/S005)Boston Scientific Neuromodulation2017-03-24
Supartz Device Family (P980044/S037)Seikagaku Corp.2017-03-21
Gel-One (P080020/S025)Seikagaku Corp.2017-03-21
Oxford Partial Knee System (P010014/S061)Biomet Manufacturing Corp2017-03-11
GELSYN-3 (P110005/S002)Ibsa Institut Biochimique SA2017-03-10
COFLEX INTERLAMINAR TECHNOLOGY (P110008/S007)Companion Spine France2017-03-10
Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S064)Medtronic Sofamor Danek USA, Inc.2017-03-03
MOBI-C CERVICAL DISC PROSTHESIS (P110009/S016)Highridge Medical, LLC2017-03-03
Infuse Bone Graft (P000054/S046)Medtronic Sofamor Danek USA, Inc.2017-03-03
MOBI-C CERVICAL DISC PROSTHESIS. (P110002/S016)Highridge Medical, LLC2017-03-03
CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S005)Cartiva, Inc.2017-03-01
OXFORD PARTIAL KNEE SYSTEM -MENISCAL BEARINGS (P010014/S060)Biomet Manufacturing Corp2017-02-27
LCS(R) TOTAL KNEE SYSTEM (P830055/S180)Depuy, Inc.2017-02-21
CERAMAX CERAMIC HIP SYSTEM (P070026/S045)DePuy Orthopaedics, Inc.2017-02-21
SUPERION INTERSPINOUS SPACER (P140004/S007)Boston Scientific Neuromodulation2017-02-21
INFUSE BONE GRAFT (P000054/S045)Medtronic Sofamor Danek USA, Inc.2017-02-16
INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE (P000058/S063)Medtronic Sofamor Danek USA, Inc.2017-02-16
GEL-ONE (P080020/S024)Seikagaku Corp.2017-01-19
SUPARTZ FX & VISCO-3 (P980044/S036)Seikagaku Corp.2017-01-19
SYNVISC (P940015/S038)Sanofi Genzyme Corp.2017-01-18
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S048)Zimmer, Inc.2017-01-12
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S042)Smith & Nephew, Inc.2017-01-12
EXOGEN ULTRASOUND BONE HEALING SYSTEM (P900009/S041)Bioventus, LLC2017-01-12
CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S004)Cartiva, Inc.2017-01-06
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S044)DePuy Orthopaedics, Inc.2017-01-03
R3 DELTA CERAMIC HIP SYSTEM (P150030/S001)Smith & Nephew, Inc.2016-12-21
BIRMINGHAM HIP SYSTEM (BHR) (P040033/S030)Smith & Nephew, Inc.2016-12-21
CORMET HIP RESURFACING SYSTEM (P050016/S011)Corin USA2016-12-21
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S038)Smith & Nephew, Inc.2016-12-21
GEL-ONE (P080020/S023)Seikagaku Corp.2016-12-19
PRESTIGE LP CERVICAL DISC (P090029/S006)Medtronic Sofamor Danek USA, Inc.2016-12-15
ATTUNE TOTAL KNEE SYSTEM (P830055/S176)Depuy, Inc.2016-12-13
BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S028)Ahp Eos Buyer, Inc.2016-12-08
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S041)Smith & Nephew, Inc.2016-12-08
BIOMET EBI BONE HEALING SYSTEM (P790002/S036)Ahp Eos Buyer, Inc.2016-12-08
Spinal-Stim (P850007/S035)Orthofix, Inc.2016-12-02
Cervical-Stim (P030034/S009)Orthofix, Inc.2016-12-02
coflex® Interlaminar Technology (P110008/S006)Companion Spine France2016-11-30
LCS(R) TOTAL KNEE SYSTEM (P830055/S178)Depuy, Inc.2016-11-28
CERAMAX CERAMIC HIP SYSTEM (P070026/S043)DePuy Orthopaedics, Inc.2016-11-28
GEL-ONE (P080020/S022)Seikagaku Corp.2016-11-23
LCS(R) TOTAL KNEE SYSTEM (P830055/S177)Depuy, Inc.2016-11-22
HYMOVIS (P150010/S001)Fidia Farmaceutici2016-11-22
Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6 (P850035/S043)Ahp Eos Buyer, Inc.2016-11-17
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S047)Zimmer, Inc.2016-11-16
Oxford Partial Knee System - Bearing Components (P010014/S058)Biomet Manufacturing Corp2016-11-09
REFLECTION CERAMIC ACETABULAR SYSTEM (P030022/S040)Smith & Nephew, Inc.2016-11-09
SYNVISC (P940015/S037)Sanofi Genzyme Corp.2016-11-08
Oxford Partial Knee System (P010014/S059)Biomet Manufacturing Corp2016-11-04
CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S003)Cartiva, Inc.2016-11-01
Oxford Partial Knee System (P010014/S056)Biomet Manufacturing Corp2016-10-21
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