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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
LIGAFIX INTERFERENCE SCREW (K122228)Sbm Sciences For Bio Materials2012-10-03
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED (K122123)Depuy Mitek, Inc., A Johnson and Johnson Company2012-10-02
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW (K120148)Advanced Orthopaedic Solutions, Inc.2012-10-02
REVERE STABILIZATION SYSTEM (K122226)Globus Medical, Inc.2012-10-01
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES (K122308)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012-10-01
SOLSTICE CROSS CONNECTOR (K120998)Life Spine2012-10-01
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM (K120891)Ulrich GmbH & Co. KG2012-10-01
AFT PROXIMAL HUMERUS FRACTURE PLATE (K121672)Shoulder Options, Inc.2012-10-01
NOVATION LPI PRIME FEMORAL STEM (K121684)Exactech, Inc.2012-10-01
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM (K121425)Wrightmedicaltechnologyinc2012-10-01
GMK NARROW (K122232)Medacta International2012-09-28
MPACT EXTENSION (K122641)Medacta International2012-09-28
CD HORIZON SPINAL SYSTEM (K122433)Medtronic Sofamor Danek, Inc.2012-09-28
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122033)Conformis, Inc.2012-09-27
PMT BONE SCREWS (K121713)Providence Medical Technology, Inc.2012-09-27
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT (K122623)Advanced Orthopaedic Solutions, Inc.2012-09-26
ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K121567)Accel Spine2012-09-26
BENCOX FORET & BENCOX DELTA (K121665)Corentec Co., Ltd.2012-09-25
DALI SPINAL FIXATION SYSTEM (K121568)Accel Spine2012-09-21
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER (K120943)ArthroCare Corporation2012-09-21
NEXTGEN ALTIUS OCT SYSTEM (K122378)Biomet Spine (Aka Ebi, LLC)2012-09-20
STERISPINE LC CAGE (K122021)Safe Orthopaedics2012-09-20
METS MODULAR PROXIMAL FEMUR (K121056)Stanmore Implants Worldwide , Ltd.2012-09-20
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541)Orthofix Srl2012-09-20
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K121302)Biomet Microfixation2012-09-19
METS MODULAR DISTAL FEMUR (K121029)Stanmore Implants Worldwide , Ltd.2012-09-19
METS MODULAR TOTAL FEMUR (K121055)Stanmore Implants Worldwide , Ltd.2012-09-19
ENDURAMESH (K122622)Lucero Medical, LLC2012-09-19
BICERA (TM) RESORBABLE BONE SUBSTITUTE (K110949)Wiltrom Corporation Limited2012-09-18
CLYDESDALE SPINAL SYSTEM (K122591)Medtronic Sofamor Danek, Inc.2012-09-18
KMC KYPHOPLASTY SYSTEM (K113742)Shanghai Kinetic Medical Co., Ltd.2012-09-17
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER (K113296)Zimmer, Inc.2012-09-14
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (K121575)Ortho Solutions Limited2012-09-14
METAFIX FEMORAL HIP STEM SIZE 1 (K121439)Corin USA2012-09-14
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM (K121078)Accel Spine2012-09-13
JAZZ SYSTEM (K121541)Implanet, S.A.2012-09-13
RANGE SPINAL SYSTEM (K121630)K2m, Inc.2012-09-11
QUINTEX CERVICAL PLATING SYSTEM (K121801)Aesculap Implant Systems, LLC2012-09-11
NUVASIVE PRECEPT SPINAL SYSTEM (K122352)Nuvasive, Inc.2012-09-11
LANX SPINAL FIZATION SYSTEM (K121316)Lanx, Inc.2012-09-10
TAPERSET HIP SMALL STEMS (K121935)Consensus Orthopedics, Inc.2012-09-10
UNITY TOATAL KNEE SYSTEM (K113060)Corin USA2012-09-10
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG (K120924)Corentec Co., Ltd.2012-09-10
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS (K121714)Smith & Nephew, Inc.2012-09-07
DEPUY CTA REVERSE SHOULDER SYSTEM (K122442)Depuy France2012-09-06
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF (K113648)Aap Implantate AG2012-09-06
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K121974)Conformis, Inc.2012-09-06
MAXLOCK EXTREME SYSTEM (K122005)Orthohelix Surgical Designs, Inc.2012-09-06
METS SMILES TOTAL KNEE REPLACEMENT (K120992)Stanmore Implants Worldwide , Ltd.2012-09-05
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM (K122216)Reliance Medical Systems, LLC2012-09-05
IOI TOTAL HIP (K121034)Iconacy Orthopedic Implants, LLC2012-09-04
ORTHOFIX GALAXY FIXATION SYSTEM (K113770)Orthofix Srl2012-09-04
ALAMO P (K122047)Alliance Partners, LLC2012-09-04
STALIF C (K120819)Centinel Spine, Inc.2012-08-31
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T (K113652)Aap Implantate AG2012-08-30
CERVICAL CAGE (K122444)Eisertech, LLC2012-08-30
NEURO VENTION LAMINPLASTY PLATING SYSTEM (K121276)Neurovention, LLC2012-08-29
STAXX XD SYSTEM (K121889)Spine Wave, Inc.2012-08-29
TETRIS II (K122317)Signus Medizintechnik GmbH2012-08-29
CAPSTONE SPINAL SYSTEM (K121760)Medtronic Sofamor Danek USA, Inc.2012-08-29
XIA 3 SPINAL SYSTEM (K113666)Stryker Spine2012-08-28
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING (K122296)Smith & Nephew, Inc.2012-08-28
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY (K121482)Theken Spine, LLC2012-08-28
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S (K121103)Ldr Spine USA, Inc.2012-08-24
PHANTOM PLUS CERAMIC CAGE SYSTEM (K121892)Amedica Corp.2012-08-24
ZIMMER TRABECULAR METAL TOTAL ANKLE (K120906)Zimmer, Inc.2012-08-24
NUVASIVE POLYAXIAL SPINAL SCREWS (K121619)Nuvasive, Inc.2012-08-24
TRANS1 INTERBODY FUSION SYSTEM (K120991)Trans1 Incorporated2012-08-23
POLARCUP DUAL MOBILITY SYSTEM (K122244)Smith & Nephew, Inc.2012-08-23
GENESYS PRESSFT SUTURE ANCHOR (K121890)Linvatec Corporation D/B/A Conmed Linvatec2012-08-22
CD HORIZON SPINAL SYSTEM (K121764)Medtronic Sofamor Danek, Inc.2012-08-21
AVS AS PEEK SPACER (K120486)Stryker Spine2012-08-20
GRIDLOCK PLATING SYSTEM (K121452)Trilliant Surgical, Ltd.2012-08-20
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D (K121148)Medical Design, LLC2012-08-20
TAPERLOC COMPLETE SIZE 4MM AND XR 123 (K120030)Biomet Manufacturing Corp2012-08-17
LANX SPINAL FIXATION SYSTEM (K122145)Lanx, Inc.2012-08-17
STGC (K121176)Cardinal Spine, LLC2012-08-17
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K121548)Spine View, Inc.2012-08-16
ALTOMEC ARTHROSCOPE (K112548)Altomec Endoscopy, Inc.2012-08-15
4CIS VANE SPINE SYSTEM (K121615)Solco Biomedical Co., Ltd.2012-08-15
MOVATION KNEE SYSTEM (K121727)Encore Medical L.P.2012-08-15
JOURNEY II CR KNEE SYSTEM (K121443)Smith & Nephew, Inc.2012-08-13
ERISMA-LP (K120469)Clariance2012-08-13
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE (K121320)Medyssey Co, Ltd.2012-08-10
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT (K120715)Zimmer GmbH2012-08-10
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM (K121136)Accel Spine2012-08-09
PROFEMUR Z REVISION HIP STEM (K121221)Wrightmedicaltechnologyinc2012-08-09
ESPIN (K120553)Nlt Spine, Ltd.2012-08-09
PICASSO MIS SPINAL FIXATION SYSTEM (K120714)Accel Spine2012-08-09
REFORM PEDICLE SCREW SYSTEM (K121172)Spinal USA2012-08-08
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION (K121393)Smith & Nephew, Inc.2012-08-07
NAUTILUS SPINAL SYSTEM (K111953)Life Spine2012-08-07
LANX SPINAL FIXATION SYSTEM (K121940)Lanx, Inc.2012-08-02
SYNTHES MATRIX SYSTEM (K120838)Synthes Spine2012-07-31
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM (K120467)Spinal Elements, Inc.2012-07-30
HIP SYSTEMS (K121308)Howmedica Osteonics Corp.2012-07-30
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD (K121299)Safe Orthopaedics2012-07-30
DYNASTY BIOFOAM SHELL (K121544)Wrightmedicaltechnologyinc2012-07-30
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM (K121569)Accel Spine2012-07-27
VEGA KNEE SYSTEM (K121879)Aesculap Implant Systems2012-07-27
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