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Orthopedic

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

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RecordFirmDate
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM (K102095)Suspension Orthopaedic Solutions, LLC2010-12-07
VIPER SYSTEM, EXPEDIUM SYSTEM (K101993)Depuy Spine, Inc.2010-12-07
KLASSIC HD HIP SYSTEM (K100445)Total Joint Orthopedics, Inc.2010-12-03
MERETE LOCKING BONE PLATE SYSTEM II (K102688)Merete Medical GmbH2010-12-03
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (K101730)Zimmer, Inc.2010-12-03
ANYPLUS PEEK CAGES (K100516)GS Medical Co., Ltd.2010-12-03
BIOPRO POLAR HEAD (K100761)Biopro, Inc.2010-12-03
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER (K101229)Zimmer, Inc.2010-12-03
PATRIOT TRANSCONTINENTAL M SPACERS (K102313)Globus Medical, Inc.2010-12-03
EVOLVE EPS ORTHOLOC (K102352)Wrightmedicaltechnologyinc2010-12-02
LAMINOPLASY PLATING SYSTEM (K103284)Aesculap Implant Systems, Inc.2010-12-02
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS (K101126)Core Essence Orthopaedics, Inc.2010-12-02
CONSENSUS TAPERSET HIP SYSTEM (K102399)Consensus Orthopedics, Inc.2010-12-02
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM (K102514)Nuvasive, Inc.2010-12-01
CONCORDE CURVE SYSTEM (K101923)Depuy Spine2010-12-01
STAXX(R) XD SYSTEM (K102682)Spine Wave, Inc.2010-11-30
AXLE INTERSPINOUS FUSION SYSTEM (K101471)X-Spine Systems, Inc.2010-11-24
HTO PLATING SYSTEM (K102505)Aesculap Implant Systems, LLC2010-11-24
ARROW ANATOMICAL SHOULDER SYSTEM (K093599)Fournitures Hospitalieres Industrie2010-11-24
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW (K102429)Wrightmedicaltechnologyinc2010-11-23
TRINITY ACETABULAR SYSTEM (K093472)Corin USA2010-11-23
DEPUY RECLAIM REVISION HIP SYSTEM (K102080)Depuy(Ireland)2010-11-23
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM (K102343)Emerge Medical2010-11-23
LOCKING BONE SCREW MODEL HCQ04, HCZ04 (K100721)Changzhou Orthmar Medical Instrument Co., Ltd.2010-11-23
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT (K103104)Howmedica Osteonics Corp.2010-11-22
CSTS SCREW (K093055)Orthopro, LLC2010-11-22
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS (K103124)Stryker Corporation2010-11-19
CD HORIZON SPINAL SYSTEM (K102807)Medtronic Sofamor Danek, Inc.2010-11-17
MOUNTAINEER OCT SPINAL SYSTEM (K103100)Depuy Spine, Inc.2010-11-17
CD HORIZON SPINAL SYSTEM (K102555)Medtronic Sofamor Danek USA, Inc.2010-11-17
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K100888)Lanx, Inc.2010-11-15
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR (K102326)Parcus Medical, LLC2010-11-15
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM (K102204)Choicespine, LP2010-11-15
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS (K103012)Exactech, Inc.2010-11-10
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR (K102162)Parcus Medical, LLC2010-11-10
KIRSCHNER WIRES, STEINMAN PINS (K102215)Evergreen Orthopedic Research Lab2010-11-09
LOCKING COMPRESSION PLATE (K101400)Changzhou Orthmed Medical Instrument Co., Ltd.2010-11-09
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM (K103007)Tornier, Inc.2010-11-09
INTERFACE (K092541)Biostructures2010-11-09
MODIFICATION TO: OASYS SYSTEM (K101183)Stryker Spine2010-11-09
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER (K101808)Medshape Solutions2010-11-08
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 (K102487)Exactech, Inc.2010-11-08
LIFE SPINE INTERSPINOUS FIXATION SYSTEM (K100407)Life Spine2010-11-05
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE (K102975)Exactech, Inc.2010-11-05
ENDOSKELETON TO (K102067)Titan Spine, LLC2010-11-05
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (K102820)Alphatec Spine, Inc.2010-11-05
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) (K102951)Exactech, Inc.2010-11-04
RELIANCE SPINAL SCREW SYSTEM (K101112)Reliance Medical Systems2010-11-04
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) (K102072)Memometal Technologies2010-11-03
SPEEDFIX SUTURE SYSTEM (K101437)Arthrocare Corp.2010-10-29
ARROWHEAD FIXATION DEVICE (K100926)Arrow Products, Inc.2010-10-29
DEPUY PINNACLE ALTRX ACETABULAR LINERS (K102423)DePuy Orthopaedics, Inc.2010-10-29
FM-02 BONE GRAFT SUBSTITUTE (K102545)Orthovita, Inc.2010-10-27
ARTHREX PUSHLOCK ANCHORS (K101679)Arthrex, Inc.2010-10-22
QUANTUM RING FIXATION SYSTEM MODEL ISF (K101759)Quantum Medical Concepts, LLC2010-10-22
PIONEER SPINOUS PROCESS FUSION PLATE (K101525)Pioneer Surgical Technology2010-10-22
CLAVICLE LOCKING PLATE SYSTEM (K100944)Newclip Technics2010-10-22
VANGUARD 360 REVISION KNEE SYSTEM (K093293)Biomet, Inc.2010-10-22
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (K102262)Arthrocare Corp.2010-10-21
T2 XVBR 1.5 SPINAL SYSTEM (K100976)Medtronic Sofamor Danek USA, Inc.2010-10-21
VIPER SPINE SYSTEM (K102701)Depuy Spine, Inc.2010-10-20
CONTOURS VSP III VOLAR PLATING SYSTEM (K101936)Orthofix, Inc.2010-10-20
INTRAFIX TIBIAL SHEATH (K102443)Depuy Mitek, A Johnson & Johnson Company2010-10-20
PIONEER CANNULATED SCREW SYSTEM (K102903)Pioneer Surgical Technology, Inc.2010-10-20
BIO-MODULAR REVERSE SHOLDER (K093803)Biomet Manufacturing Corp2010-10-19
MODIFICATION TO:EXPEDIUM SPINE SYSTEM (K101933)Depuy Spine, Inc.2010-10-18
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP (K093471)KARL STORZ Endoscopy-America, Inc.2010-10-18
KAPSS SPINAL SYSTEM (K093833)Robert Reid, Inc.2010-10-15
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM (K102331)Ldr Spine USA2010-10-15
KYPHON XPANDER II INFLATABLE BONE TAMP (K101864)Medtronic2010-10-14
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM (K101848)Spinal Elements, Inc.2010-10-14
SMALL PLATEAU SPACER SYSTEM (K093093)Life Spine2010-10-13
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM (K101700)Extremity Medical, LLC2010-10-12
UNITED U2 BIPOLAR IMPLANT (K101670)United Orthopedic Corp.2010-10-08
EXCELLA II SPINAL SYSTEM MODEL EC2-00 (K102248)Innovasis, Inc.2010-10-07
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM (K101939)Merete Medical GmbH2010-10-07
ACUMED WRIST ARTHRODESIS PLATE SYSTEM (K100123)Acumed, LLC2010-10-06
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (K102277)Vertebral Technologies, Inc.2010-10-06
CONSENSUS CS2 PLUS ACETABULAR INSERT (K100933)Consensus Orthopedics, Inc.2010-10-06
PARADIGM INTERSPINOUS FUSION PLATE (K093438)Paradigm Spine, LLC2010-10-06
JOURNEY UNICONDYLAR TIBIAL BASEPLATES (K102069)Smith & Nephew, Inc.2010-10-05
CASPIAN SPINAL SYSTEM (K101084)K2m, Inc.2010-10-04
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM (K092723)Skeletal Dynamics, LLC2010-10-04
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS (K101622)Zimmer, Inc.2010-10-01
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM (K100042)Difusion Technologies2010-10-01
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS (K102156)Orthohelix Surgical Designs, Inc.2010-09-30
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM (K102090)Spine Smith Partners L.P.2010-09-30
TSRH(R) SPINAL SYSTEM (K101772)Medtronic Sofamor Danek2010-09-30
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM (K102265)Ldr Spine USA2010-09-29
DEPUY UNIVERSAL GRIPTION TF CONES (K100391)DePuy Orthopaedics, Inc.2010-09-29
EBERLE SHAVER SYSTEM ACCESSORIES (K092977)Efs Eberle Feinwerktechnische Systeme2010-09-29
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956)Encore Medical L.P.2010-09-28
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) (K100112)Sonoma Orthopedic Products, Inc.2010-09-28
APEX KNEE MODULAR TIBIA SYSTEM (K101994)Omnlife Science2010-09-28
CONSTRUX MINI PEEK SPACER SYSTEM (K101812)Orthofix, Inc.2010-09-27
MINI MAXLOCK EXTREME PLATING SYSTEM (K101962)Orthohelix Surgical Designs, Inc.2010-09-27
CD HORIZON SPINAL SYSTEM (K091445)Medtronic Sofamor Danek2010-09-27
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM (K093047)Smith & Nephew, Inc.2010-09-27
STALIF MIDLINE (K101301)Centinel Spine2010-09-24
GMK REVISION KNEE SYSTEM (K102437)Medacta International S.A.2010-09-24
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