meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
43
Latest Decision
2011-01-19

Clearances · page 81 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102370 R3 XLPE ANTEVERTED LINERS Smith & Nephew, Inc. MBL Class II 2011-01-19
K083894 ALIF SPINAL TRUSS INTERBODY FUSION DEVICE 4-Web Spine, LLC MAX Class II 2011-01-18
K103133 VEPER SYSTEM, EXPEDIUM SYSTEM Depuy Spine, Inc. NKB Class II 2011-01-18
K103068 KING COBRA ANTERIOR CERVICAL PLATE Eminent Spine KWQ Class II 2011-01-14
K102885 HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX Stryker Corp. JEC Class II 2011-01-14
K101336 E1 AVANTAGE HEAD Biomet Manufacturing Corp LPH Class II 2011-01-14
K102601 ORTHOFLEX ROD Ortho-Pro, LLC KWH Class II 2011-01-14
K103232 CASPIAN SPINAL SYSTEM K2m, Inc. KWP Class II 2011-01-13
K102834 ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) Kinamed, Incorporated JDQ Class II 2011-01-12
K102121 ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR Apollo Spine, Inc. OVD Class II 2011-01-12
K103070 GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + G Surgical Co., Ltd. KWQ Class II 2011-01-12
K103033 TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX Zimmer Trabecular Metal Technology ODP Class II 2011-01-10
K103036 ALLOFUSE PLUS Allosource, Inc. MQV Class II 2011-01-10
K103064 AVAMAX VERTEBRAL BALLOON Care Fusion NDN Class II 2011-01-10
K102322 STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) Omni Surgical, L.P. MAX Class II 2011-01-07
K103117 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2011-01-07
K101823 ARTHREX SWIVELOCK ANCHORS Arthrex, Inc. MAI Class II 2011-01-07
K101588 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL Apollo Spine, Inc. OVE Class II 2011-01-07
K102298 TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND Depuy Mitek, A Johnson & Johnson Company HWC Class II 2011-01-07
K102380 EVOLUTION MP TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc JWH Class II 2011-01-07
K101616 THE GRAPPLR AND GRAPPLR EXTENDER Tag Medical Corp. MBI Class II 2011-01-06
K102293 CALIBER SPACER Globus Medical, Inc. MAX Class II 2011-01-05
K103228 PARAMOUNT R IBF DEVICE Theken Spine, LLC MAX Class II 2011-01-05
K101472 MULTIFIT TOTAL HIP SYSTEM Otis Biotech Co., Ltd. LZO Class II 2011-01-05
K103287 SYNTHES 6.0 COCR AND CPT TI-3 RODS Synthes Spine NKB Class II 2011-01-05
K102982 ENDOBUTTON DIRECT Smith & Nephew Inc., Endoscopy Division MAI Class II 2011-01-05
K103060 ARTHREX TIBIAL GRAFTBOLT Arthrex, Inc. MBI Class II 2011-01-05
K102998 CONGRUENT BONE PLATE SYSTEM Acumed, LLC HRS Class II 2011-01-04
K103433 F20 Teknimed, S.A. NDN Class II 2011-01-03
K103272 ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. MNI Class II 2010-12-29
K101837 ACL TIGHTROPE DOUBLE BUNDLE Arthrex, Inc. HTY Class II 2010-12-28
K102937 OSTEOPHIL BETA-TCP Cytophil, Inc. MQV Class II 2010-12-27
K103049 TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2010-12-23
K103466 ARTHREX UNIVERS II SHOULDER PROSTHESIS Arthrex, Inc. KWS Class II 2010-12-22
K102565 ANTERIOR APPROACH HIP SURGERY INSTRUMENTS Wrightmedicaltechnologyinc KWA Class III 2010-12-22
K102992 T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES Howmedica Osteonics Corp. HSB Class II 2010-12-22
K102392 MICROFUSE PUTTY AND MICROFUSE ST MIS Globus Medical, Inc. MQV Class II 2010-12-22
K103223 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS Encore Medical L.P. OIY Class II 2010-12-21
K102410 MATRYX INTERFERENCE SCREW (5.0-6.5MM) Conmed Linvatec HWC Class II 2010-12-21
K102057 TARGON FN SYSTEM Aesculap Implant Systems, LLC KTT Class II 2010-12-21
K102777 TWISTCUT ENDOSORB SCREWS Merete Medical GmbH JDW Class II 2010-12-20
K102180 RHEAD RADIAL HEAD EXTENDED STEMS Small Bone Innovations, Inc. JDB Class II 2010-12-20
K103189 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK Medacta International S.A. LZO Class II 2010-12-20
K101815 ENDURO KNEE SYSTEM Aesculap Implant Systems KRO Class II 2010-12-20
K093762 SYNTHES ZERO-P Synthes Spine OVE Class II 2010-12-20
K101278 INERTIA PEDICLE SCREW SYSTEM Nexxt Spine, LLC MNH Class II 2010-12-20
K101363 VU CPOD INTERVERTEBRAL BODU FUSION DEVICE Musculoskeletal Clinical Regulatory Advisers ODP Class II 2010-12-16
K102249 EXPEDIUM SPINE SYSTEM Depuy Spine, A Johnson & Johnson Company NKB Class II 2010-12-16
K102323 CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC OVE Class II 2010-12-16
K103408 POSTERIOR LATERAL PLATES DePuy Orthopaedics, Inc. HRS Class II 2010-12-16
K103147 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM Medyssey Co, Ltd. MNI Class II 2010-12-16
K102201 CONTOURS LAPIDUS PLATING SYSTEM Orthofix, Inc. HRS Class II 2010-12-15
K101996 DEPUY GLOBAL UNITE SHOULDER SYSTEM Depuy(Ireland) PHX Class II 2010-12-15
K103374 INBONE TOTAL ANKLE SYSTEM MODEL 200347902 Wrightmedicaltechnologyinc HSN Class II 2010-12-14
K102907 SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. OUR Class II 2010-12-14
K102660 BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS Smith & Nephew Endoscopy, Inc. MBI Class II 2010-12-13
K103419 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM Exactech, Inc. KWS Class II 2010-12-13
K102896 TRABECULAR METAL TIBIAL CONE AUGMENTS Zimmer Trabecular Metal Technology MBH Class II 2010-12-13
K102537 APTUS 1.5 TRILOCK Medartis AG HRS Class II 2010-12-10
K101433 DEPUY ATTUNE KNEE SYSTEM DePuy Orthopaedics, Inc. OIY Class II 2010-12-10
K103034 GENESYS SPINE INTERBODY FUSION SYSTEM Genesys Spine MAX Class II 2010-12-10
K100858 LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, Lima-Lto S.P.A. KWT Class II 2010-12-10
K102488 APEX SPINE SYSTEM W/ COCR RODS Spinecraft, LLC MNH Class II 2010-12-10
K102694 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa) HRS Class II 2010-12-09
K101609 SELF RETAINING SOFT TISSUE RETRACTOR Koros USA, Inc. LXH Class I 2010-12-09
K102424 PREVISION HIP SYSTEM WITH RECON RING Aesculap Implant Systems, LLC MEH Class II 2010-12-09
K102143 SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM Suspension Orthopaedic Solutions, LLC JDR Class II 2010-12-08
K102367 OPTIGEN TOTAL KNEE SYSTEM U&I Corp. JWH Class II 2010-12-08
K101993 VIPER SYSTEM, EXPEDIUM SYSTEM Depuy Spine, Inc. NKB Class II 2010-12-07
K101682 S 100 PEDICLE SCREW SYSTEM Renovis Surgical Technologies, LLC MNI Class II 2010-12-07
K100469 ARCOS INTERLOCKING DISTAL STEMS Biomet Manufacturing Corp KWA Class III 2010-12-07
K102095 SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM Suspension Orthopaedic Solutions, LLC HRS Class II 2010-12-07
K102282 THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics HRS Class II 2010-12-07
K100516 ANYPLUS PEEK CAGES GS Medical Co., Ltd. OVD Class II 2010-12-03
K100761 BIOPRO POLAR HEAD Biopro, Inc. KWY Class II 2010-12-03
K101730 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS Zimmer, Inc. KWZ Class II 2010-12-03
K101229 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER Zimmer, Inc. LPH Class II 2010-12-03
K102313 PATRIOT TRANSCONTINENTAL M SPACERS Globus Medical, Inc. MAX Class II 2010-12-03
K102688 MERETE LOCKING BONE PLATE SYSTEM II Merete Medical GmbH KTT Class II 2010-12-03
K100445 KLASSIC HD HIP SYSTEM Total Joint Orthopedics, Inc. LPH Class II 2010-12-03
K101126 PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS Core Essence Orthopaedics, Inc. MBI Class II 2010-12-02
K103284 LAMINOPLASY PLATING SYSTEM Aesculap Implant Systems, Inc. NQW Class II 2010-12-02
K102399 CONSENSUS TAPERSET HIP SYSTEM Consensus Orthopedics, Inc. LPH Class II 2010-12-02
K102352 EVOLVE EPS ORTHOLOC Wrightmedicaltechnologyinc HRS Class II 2010-12-02
K101923 CONCORDE CURVE SYSTEM Depuy Spine MAX Class II 2010-12-01
K102514 NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM Nuvasive, Inc. NKB Class II 2010-12-01
K102682 STAXX(R) XD SYSTEM Spine Wave, Inc. MQP Class II 2010-11-30
K102505 HTO PLATING SYSTEM Aesculap Implant Systems, LLC HRS Class II 2010-11-24
K093599 ARROW ANATOMICAL SHOULDER SYSTEM Fournitures Hospitalieres Industrie KWS Class II 2010-11-24
K101471 AXLE INTERSPINOUS FUSION SYSTEM X-Spine Systems, Inc. KWP Class II 2010-11-24
K100721 LOCKING BONE SCREW MODEL HCQ04, HCZ04 Changzhou Orthmar Medical Instrument Co., Ltd. HWC Class II 2010-11-23
K102429 ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW Wrightmedicaltechnologyinc HRS Class II 2010-11-23
K102343 EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM Emerge Medical HWC Class II 2010-11-23
K102080 DEPUY RECLAIM REVISION HIP SYSTEM Depuy(Ireland) LZO Class II 2010-11-23
K093472 TRINITY ACETABULAR SYSTEM Corin USA MEH Class II 2010-11-23
K103104 SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT Howmedica Osteonics Corp. KWS Class II 2010-11-22
K093055 CSTS SCREW Orthopro, LLC HWC Class II 2010-11-22
K103124 SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS Stryker Corporation LPH Class II 2010-11-19
K103100 MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. MNI Class II 2010-11-17
K102555 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2010-11-17

17,115 clearances in the Orthopedic panel. Data: openFDA.