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Orthopedic

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

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RecordFirmDate
R3 DELTA CERAMIC HIP SYSTEM (P150030)Smith & Nephew, Inc.2016-10-17
OXFORD PARTIAL KNEE SYSTEM (P010014/S057)Biomet Manufacturing Corp2016-10-13
LCS TOTAL KNEE SYSTEM (P830055/S173)Depuy, Inc.2016-10-12
Superion® Interspinous Spacer (P140004/S004)Boston Scientific Neuromodulation2016-10-11
AUGMENT BONE GRAFT (P100006/S003)Biomimetic Therapeutics, LLC2016-10-06
REFLECTION CERAMIC Acetabular Hip SYSTEM (RCHS) (P030022/S037)Smith & Nephew, Inc.2016-10-04
MONOVISC (P090031/S007)Anika Therapeutics, Inc.2016-10-04
INFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM (P000058/S062)Medtronic Sofamor Danek USA, Inc.2016-09-29
CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE (P150017/S002)Cartiva, Inc.2016-09-29
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020)Exactech, Inc.2016-09-28
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R. ANKLE) (P050050/S010)Djo Global2016-09-28
GEL-ONE(R) (P080020/S020)Seikagaku Corp.2016-09-27
LCS(R) TOTAL KNEE SYSTEM (P830055/S172)Depuy, Inc.2016-09-22
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S039)DePuy Orthopaedics, Inc.2016-09-21
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S038)DePuy Orthopaedics, Inc.2016-09-21
LCS KNEE SYSTEM (P830055/S175)Depuy, Inc.2016-09-20
INFUSE BONE GRAFT (P000054/S044)Medtronic Sofamor Danek USA, Inc.2016-09-16
INFUSE BONE GRAFT/Medtronic Interbody FUSION DEVICE (P000058/S060)Medtronic Sofamor Danek USA, Inc.2016-09-16
SUPARTZ FX VISCO-3 (P980044/S035)Seikagaku Corp.2016-09-14
SUPARTZ FX, VISCO-3 (P980044/S034)Seikagaku Corp.2016-09-13
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S042)DePuy Orthopaedics, Inc.2016-09-07
LCS(R) TOTAL KNEE SYSTEM (P830055/S174)Depuy, Inc.2016-09-07
CERAMIC TRANSCEND HIP ARTICULATION (P030027/S009)Microport Orthopedics, Inc.2016-09-01
OXFORD PARTIAL KNEE SYSTEM (P010014/S055)Biomet Manufacturing Corp2016-09-01
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) (P050050/S008)Djo Global2016-09-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S046)Zimmer, Inc.2016-09-01
HYALGAN (P950027/S015)Fidia Farmaceutici S.P.A.2016-08-26
CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S001)Cartiva, Inc.2016-08-25
COFLEX® INTERLAMINAR TECHNOLOGY (P110008/S005)Companion Spine France2016-08-23
BRYAN CERVICAL DISC SYSTEM (P060023/S005)Companion Spine France Sas2016-08-11
PRESTIGE CERVICAL DISC SYSTEM (P060018/S005)Medtronic Sofamor Danek, Inc.2016-08-11
PRESTIGE LP CERVICAL DISC SYSTEM (P090029/S005)Medtronic Sofamor Danek USA, Inc.2016-08-11
LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS (P000058/S061)Medtronic Sofamor Danek USA, Inc.2016-08-11
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
GEL-ONE (P080020/S021)Seikagaku Corp.2016-07-25
SUPARTZ Device Family, Supartz FX, VISCO-3 (P980044/S033)Seikagaku Corp.2016-07-25
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S036)Smith & Nephew, Inc.2016-07-22
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019)Exactech, Inc.2016-07-21
PRESTIGE® Cervical Disc (P060018/S004)Medtronic Sofamor Danek, Inc.2016-07-20
PRESTIGE LP(TM) CERVICAL DISC (P090029/S003)Medtronic Sofamor Danek USA, Inc.2016-07-07
CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017)Cartiva, Inc.2016-07-01
LCS(R) TOTAL KNEE SYSTEM (P830055/S171)Depuy, Inc.2016-07-01
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S037)DePuy Orthopaedics, Inc.2016-07-01
AUGMENT BONE GRAFT (P100006/S004)Biomimetic Therapeutics, LLC2016-06-23
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S036)DePuy Orthopaedics, Inc.2016-06-17
ANTHOLOGY FEMORAL STEMS (P030022/S033)Smith & Nephew, Inc.2016-06-08
PRESTIGE LP CERVICAL DISC (P090029/S004)Medtronic Sofamor Danek USA, Inc.2016-06-07
LCS(R) TOTAL KNEE SYSTEM (P830055/S170)Depuy, Inc.2016-06-03
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S045)Zimmer, Inc.2016-06-01
Gel-Syn™ (P110005/S001)Ibsa Institut Biochimique SA2016-05-23
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S035)DePuy Orthopaedics, Inc.2016-05-17
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006)Globus Medical, Inc.2016-05-17
SUPARTZ FX (P980044/S032)Seikagaku Corp.2016-05-13
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S031)DePuy Orthopaedics, Inc.2016-05-04
LCS TOTAL KNEE SYSTEM (P830055/S168)Depuy, Inc.2016-05-03
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S044)Zimmer, Inc.2016-04-29
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017)Exactech, Inc.2016-04-26
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S054)Biomet Manufacturing Corp2016-04-26
LCS(R) TOTAL KNEE SYSTEM (P830055/S169)Depuy, Inc.2016-04-14
SYNVISC ONE (P940015/S036)Sanofi Genzyme Corp.2016-04-04
GEL-ONE (P080020/S008)Seikagaku Corp.2016-03-29
CERAMAX Ceramic Total Hip System (P070026/S034)DePuy Orthopaedics, Inc.2016-03-23
GEL-ONE (P080020/S019)Seikagaku Corp.2016-03-22
SUPARTZ FX (P980044/S031)Seikagaku Corp.2016-03-22
I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019/S002)Cerapedics, LLC2016-03-18
EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S042)Ahp Eos Buyer, Inc.2016-03-18
I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019/S001)Cerapedics, LLC2016-03-17
AUGMENT BONE GRAFT (P100006/S002)Biomimetic Therapeutics, LLC2016-03-16
PRESTIGE(R) LP CERVICAL DISC (P090029/S002)Medtronic Sofamor Danek USA, Inc.2016-03-11
BIO OSTEOGEN SYSTEM 204 (P790002/S035)Ahp Eos Buyer, Inc.2016-03-07
TRIDENT CERAMIC INSERT (P000013/S013)Howmedica Osteonics Corp.2016-03-04
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S016)Ceramtec GmbH2016-02-25
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S015)Ceramtec GmbH2016-02-25
MONOVISC (P090031/S006)Anika Therapeutics, Inc.2016-02-25
ORTHOVISC (P030019/S023)Anika Therapeutics, Inc.2016-02-25
LCS TOTAL KNEE SYSTEM (P830055/S167)Depuy, Inc.2016-02-24
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S017)Ceramtec GmbH2016-02-24
OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S028)Djo, LLC2016-02-18
coflex Interlaminar Technology (P110008/S004)Companion Spine France2016-02-09
PRODISC-L TOTAL DISC REPLACEMENT (P050010/S017)Centinel Spine, LLC2016-02-04
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S029)Smith & Nephew, Inc.2016-01-28
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S035)Smith & Nephew, Inc.2016-01-28
SUPARTZ FX (P980044/S028)Seikagaku Corp.2016-01-27
THE MOBI-C CERVICAL DISC PROSTHESIS (P110009/S011)Highridge Medical, LLC2016-01-27
THE MOBI-C CERVICAL DISC PROSTHESIS (P110002/S011)Highridge Medical, LLC2016-01-27
MOBI-C CERVICAL DISC PROSTHESIS (P110009/S013)Highridge Medical, LLC2016-01-21
MOBI-C CERVICAL DISC PROSTHESIS (P110002/S013)Highridge Medical, LLC2016-01-21
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S043)Zimmer, Inc.2016-01-15
BIOMET EBI BONE HEALING SYSTEM (P790002/S034)Ahp Eos Buyer, Inc.2016-01-14
SPF IMPLANTABLE SPINAL FUSION STIMULATORS (P850035/S041)Ahp Eos Buyer, Inc.2016-01-14
BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S027)Ahp Eos Buyer, Inc.2016-01-14
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S054)Ahp Eos Buyer, Inc.2016-01-14
SUPARTZ FX (P980044/S030)Seikagaku Corp.2016-01-06
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018)Exactech, Inc.2015-12-30
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S008)Microport Orthopedics, Inc.2015-12-30
LCS TOTAL KNEE SYSTEM (P830055/S165)Depuy, Inc.2015-12-23
VISCO-3 (P980044/S027)Seikagaku Corp.2015-12-21
REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS) (P030022/S034)Smith & Nephew, Inc.2015-12-17
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S053)Ahp Eos Buyer, Inc.2015-12-17
ACTIVL ARTIFICIAL DISC (P120024/S003)Highridge Medical, LLC2015-12-17
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