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Orthopedic

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

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RecordFirmDate
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
SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATORS, SPF-PLUS-MINI SPINAL FUSION STIMULATORS (P850035/S040)Ahp Eos Buyer, Inc.2015-12-17
CERAMAX CERAMIC TOTAL HIP SYSTEM. (P070026/S033)DePuy Orthopaedics, Inc.2015-12-15
SUPERION INTERSPINOUS SPACER (P140004/S002)Boston Scientific Neuromodulation2015-12-15
LCS TOTAL KNEE SYSTEM (P830055/S166)Depuy, Inc.2015-12-15
SUPERION INTERSPINOUS SPACER SYSTEM (P140004/S003)Boston Scientific Neuromodulation2015-12-11
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S024)Smith & Nephew, Inc.2015-12-11
SUPARTZ FX (P980044/S029)Seikagaku Corp.2015-12-10
CERAMAX CERAMIC HIP SYSTEM (P070026/S032)DePuy Orthopaedics, Inc.2015-12-10
INFUSE(R) BONE GRAFT (P000058/S059)Medtronic Sofamor Danek USA, Inc.2015-12-04
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S014)Ceramtec GmbH2015-12-04
GEL-ONE (P080020/S018)Seikagaku Corp.2015-11-25
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S042)Zimmer, Inc.2015-11-23
OXFORD PARTIAL KNEE SYSTEM (P010014/S053)Biomet Manufacturing Corp2015-11-20
SUPERION INTERSPINOUS SPACER (P140004/S001)Boston Scientific Neuromodulation2015-11-18
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S041)Zimmer, Inc.2015-11-12
LCS TOTAL KNEE SYSTEM (P830055/S164)Depuy, Inc.2015-11-12
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S052)Ahp Eos Buyer, Inc.2015-11-06
SPF- XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS & SPF PLUS MINI SPINAL FUSION STIMULATORS (P850035/S039)Ahp Eos Buyer, Inc.2015-11-06
BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM (P850022/S026)Ahp Eos Buyer, Inc.2015-11-06
BIOMET EBI BONE HEALING SYSTEM (P790002/S033)Ahp Eos Buyer, Inc.2015-11-06
TRIDENT (P000013/S012)Howmedica Osteonics Corp.2015-11-05
ACTIVL ARTIFICIAL DISC (P120024/S002)Highridge Medical, LLC2015-11-04
I-FACTOR PEPTIDE ENHANCED BONE GRAFT (P140019)Cerapedics, LLC2015-11-03
OXFORD PARTIAL KNEE SYSTEM (P010014/S052)Biomet Manufacturing Corp2015-10-30
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM (P060037/S040)Zimmer, Inc.2015-10-27
ACTIVL ARTIFICIAL DISC (P120024/S001)Highridge Medical, LLC2015-10-21
MOBI-C CERVICAL DISC PROSTHESIS (P110002/S010)Highridge Medical, LLC2015-10-06
NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM (P060037/S038)Zimmer, Inc.2015-10-06
MOBI-C CERVICAL DISC PROSTHESIS (P110009/S010)Highridge Medical, LLC2015-10-06
AUGMENT BONE GRAFT (P100006/S001)Biomimetic Therapeutics, LLC2015-10-05
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S032)Smith & Nephew, Inc.2015-09-25
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE (P060037/S039)Zimmer, Inc.2015-09-11
BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR (P850022/S025)Ahp Eos Buyer, Inc.2015-09-09
GENVISC 850 (P140005)Channel-Markers Medical, LLC2015-09-02
AUGMENT BONE GRAFT (P100006)Biomimetic Therapeutics, LLC2015-09-01
GEL-ONE (P080020/S017)Seikagaku Corp.2015-08-28
GEL-ONE (P080020/S016)Seikagaku Corp.2015-08-28
HYMOVIS (P150010)Fidia Farmaceutici2015-08-28
PHYSIO-STIM AND SPINAL-STIM (P850007/S034)Orthofix, Inc.2015-08-26
CERVICAL-STIM (P030034/S008)Orthofix, Inc.2015-08-26
LCS TOTAL KNEE SYSTEM (P830055/S160)Depuy, Inc.2015-08-21
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