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Orthopedic

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

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RecordFirmDate
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS (K112144)Tornier2012-03-13
NUVASIVE COROENT NO-PROFILE SYSTEM (K112561)Nuvasive, Inc.2012-03-13
ASFORA BULLET CAGE (K112648)Medical Designs, LLC2012-03-13
RELIANCE LUMBAR IBF SYSTEM (K113540)Reliance Medical Systems, LLC2012-03-12
ADAPTIVE WEDGE (K110662)Adaptive Specialty, LLC2012-03-12
PIONEER POSTERIOR CERVICO THORACIC SYSTEM (K112757)Pioneer Surgical Technology, Inc.2012-03-12
TRAUMA INTERNAL FIXATION SYSTEMS (K111663)DePuy Orthopaedics, Inc.2012-03-12
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL (K112663)Enhatch Orthopaedics, LLC2012-03-12
PIPELINE TOTAL HIP SYSTEM (K112802)Pipeline Orthopedics2012-03-09
LANX SPINAL FIXATION SYSTEM (K120399)Lanx, LLC2012-03-09
ASCEND SHOULDER SYSTEM (K113413)Tornier, Inc.2012-03-09
POWER ADAPTOR INSTRUMENT ACCESSORY (K120434)Stryker Corp.2012-03-08
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED (K120044)Arthrex, Inc.2012-03-08
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM (K120355)Phygen, LLC2012-03-07
FOOTPRINT ULTRA PK SUTURE ANCHOR (K113274)Smith & Nephew, Inc.2012-03-06
PLIF CAGE (K113478)Eisertech, LLC2012-03-05
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI (K111792)Signus Medizintechnik GmbH2012-03-05
KNOTILUS ANCHOR SYSTEM (K113297)T.A.G. Medical Products Corporation, Ltd.2012-03-02
HEALIX ADVANCE BR ANCHOR (K120078)Depuy Mitek Inc., Johnson and Johnson Company2012-02-29
2.7MM LCP ULNA OSTEOTOMY SYSTEM (K113364)Synthes (USA) Products, LLC2012-02-29
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE (K120293)Spineology, Inc.2012-02-29
VANGUARD COMPLETE KNEE SYSTEM (K113550)Biomet Manufacturing Corp2012-02-29
APEX REVISION KNEE SYSTEMS (K112891)Omni Life Science, Inc.2012-02-29
DYNANAIL ANKLE ARTHRODESIS NAIL (K113828)MedShape, Inc.2012-02-29
MECTALIF TRANSFORAMINAL (K120024)Medacta International S.A.2012-02-28
NEON SYSTEM (K113346)Ulrich GmbH & Co. KG2012-02-28
JOURNEY II DEEP DISHED ARTICULAR INSERTS (K113482)Smith & Nephew, Inc.2012-02-27
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS (K113254)Lima Corporate S.P.A.2012-02-24
LINEAR HIP STEM, SIZE 5 (K120241)Encore Medical L.P.2012-02-24
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM (K112861)Sintea Plustek, LLC2012-02-24
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (K111970)Tornier2012-02-23
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM (K120163)Acute Innovations, LLC2012-02-17
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM (K113452)Ascendx Spine, Inc.2012-02-17
WAGNER CONE PROSTHESIS SYSTEM (K113556)Zimmer GmbH2012-02-17
ARTHREX KNOTLESS SUTURETAK ANCHOR (K120155)Arthrex, Inc.2012-02-17
ICON (TM) MODULAR PEDICLE SCREW SYSTEM (K111448)Orthofix, Inc.2012-02-16
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K113518)Spinefrontier, Inc.2012-02-16
EAUM TOTAL KNEE SYSTEM (K110404)Corentec Co., Ltd.2012-02-16
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL (K120143)Apollo Spine2012-02-16
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE (K120121)Biomet, Inc.2012-02-16
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL (K113409)Howmedica Osteonics Corp.2012-02-15
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K113378)Conformis, Inc.2012-02-15
FOCUS SPINAL SYSTEM (K120140)L&K BIOMED Co., Ltd.2012-02-15
POLYFUSE - NEUROBONE (K111018)Atpac Medical, LLC2012-02-14
COFLEX-F (K112595)Paradigm Spine, LLC2012-02-13
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K113362)Spine View, Inc.2012-02-10
CD HORIZON VOYAGER SPINAL SYSTEM (K113529)Medtronic Sofamor Danek2012-02-09
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) (K120083)Synthes USA2012-02-08
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM (K113396)Medos International SARL2012-02-08
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER (K112383)Skeletal Kinetics, LLC2012-02-07
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678)Ortho Solutions Limited2012-02-07
CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS (K111481)Corin USA2012-02-06
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (K113752)Solana Surgical, LLC2012-02-06
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM (K113762)Arthrosurface, Inc.2012-02-06
PATHWAY AVID (K111726)Custom Spine, Inc.2012-02-06
PERIMETER INTERBODY FUSION DEVICE (K113642)Medtronic Sofamor Danek USA2012-02-06
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (K120029)Solana Surgical, LLC2012-02-06
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) (K120068)Conformis, Inc.2012-02-03
CORAL SPINAL SYSTEM (K120047)Theken Spine, LLC2012-02-03
CONSERVE THIN SHELL (K113322)Wrightmedicaltechnologyinc2012-02-03
SAVANNAH TECHNOLOGIES SPINAL SYSTEM (K113755)Savannah Technologies, LLC2012-02-01
KLASSIC KNEE SYSTEM (K112906)Total Joint Orthopedics, Inc.2012-02-01
SYNTHES USS CONNECTORS (K113149)Synthes Spine2012-02-01
PASS LP SPINAL (K112736)Medicrea International2012-02-01
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS (K113014)Wrightmedicaltechnologyinc2012-01-31
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS (K112526)Smith & Nephew, Inc.2012-01-31
MAXLOCK EXTREME SYSTEM (K113048)Orthohelix Surgical Designs, Inc.2012-01-30
NCB STRAIGHT NARROW SHAFT PLATES (K113718)Zimmer GmbH2012-01-27
SANTORINI SPINAL SYSTEM (K111294)K2m, Inc.2012-01-27
GMK RESUFACING PATELLA SIZE 4 (K113571)Medacta International2012-01-27
RISE SPACER (K113447)Globus Medical, Inc.2012-01-26
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786)Stryker Corp.2012-01-26
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM (K113218)Pioneer Surgical Technology, Inc.2012-01-26
GIZA(R) VERTEBRAL BODY REPLACEMENT (K112429)Eden Spine, LLC2012-01-26
GAP ENDO-EXO MEDULLARY SYSTEM (K111232)Pega Medical, Inc.2012-01-26
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE (K113030)Spineology, Inc.2012-01-26
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (K112206)Seaspine, Inc.2012-01-25
XENON(TM) PEDICLE SCREW SYSTEM (K111634)Alphatec Spine, Inc.2012-01-25
MTF NEW BONE VOILD FILLER (K113167)Musculoskeletal Transplant Foundation2012-01-24
IVAS BALLOON CATHETER (K113154)Stryker Corporation2012-01-24
SYNDE-LOCK SYNDESMOSIS REPAIR KIT (K111971)Tarsus Medical, Inc.2012-01-23
LEXUS ANTERIOR CERVICAL PLATE SYSTEM (K113509)L&K BIOMED Co., Ltd.2012-01-20
RELIANCE SPINAL SCREW SYSTEM (K110896)Reliance Medical Systems, LLC2012-01-20
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR (K113294)Smith & Nephew, Inc.2012-01-20
OPTICAGE INTERBODY FUSION DEVICE (K113527)Interventional Spine, Inc.2012-01-20
OASYS SPINAL SYSTEM (K111719)Stryker Spine2012-01-19
NANOVIS SPINAL SYSTEM (K113173)Nanovis, LLC2012-01-19
CUFFINK (K112814)Cayenne Medical, Inc.2012-01-17
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS (K113730)Parcus Medical, LLC2012-01-17
K2M, PYRENEES CERVICAL PLATE SYSTEM (K113329)K2m, Inc.2012-01-17
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM (K113366)Phygen, LLC2012-01-17
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K113252)Medtronic Sofamor Danek2012-01-17
VARIOUS (K112417)Depuy Mitek, A Johnson & Johnson Company2012-01-13
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL (K112727)Medical Facets2012-01-13
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM (K113123)The Orthopaedic Implant Company2012-01-12
CASPIAN (K113654)K2m, Inc.2012-01-12
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (K113318)Acute Innovations, LLC2012-01-12
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY (K113069)Biomet Manufacturing Corp2012-01-11
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM (K113405)Suspension Orthopaedic Solutions, LLC2012-01-11
DSS STABILIZATION SYSTEM (K113625)Paradigm Spine, LLC2012-01-10
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