meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2014-08-18

Clearances · page 61 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141044 M.U.S.T. EXTENSION Medacta International NKB Class II 2014-08-18
K141653 BIOLOX DELTA CERAMIC OPTION HEADS Biomet, Inc. LZO Class II 2014-08-18
K141129 EXACTECH CERVICAL SPACER SYSTEM Exactech, Inc. ODP Class II 2014-08-15
K141735 ARTHREX ANKLE FUSION PLATING SYSTEM Arthrex, Inc. HRS Class II 2014-08-15
K132049 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS Choicespine NKB Class II 2014-08-15
K141141 KIVA VCF TREATMENT SYSTEM Benvenue Medical, Inc. NDN Class II 2014-08-14
K140508 ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS Zimmer, Inc. HRS Class II 2014-08-14
K141956 FIBERGRAFT BG MORSELS Prosidyan, Inc. MQV Class II 2014-08-13
K140476 ARTHREX FIBERTAK SUTURE ANCHOR Arthrex, Inc. MBI Class II 2014-08-13
K141734 ZIMMER PERIARTICULAR LOCKING SYSTEM Zimmer, Inc. HRS Class II 2014-08-13
K141517 ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES Zimmer, Inc. HRS Class II 2014-08-13
K141005 Z-LINK CERVICAL Zavation, LLC OVE Class II 2014-08-07
K141823 AAP LOQTEC CLAVICLE PLATES 2.7/3.5 Aap Implantate AG HRS Class II 2014-08-07
K141241 MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM Synthes (USA) Products, LLC HRS Class II 2014-08-07
K141992 VARIAX 2 SYSTEM Stryker Trauma AG HRS Class II 2014-08-07
K140563 LATERAL VBR SYSTEM Nu Vasive, Incorporated MQP Class II 2014-08-07
K141327 MINIMA S SYSTEM Lima Corporate S.P.A. LZO Class II 2014-08-06
K140478 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier S.A.S. PHX Class II 2014-08-06
K141494 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2014-08-06
K141056 TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS Stryker Orthopaedics MBH Class II 2014-08-05
K141746 AS20 COMPOSITE GRAFT Wrightmedicaltechnologyinc MQV Class II 2014-08-04
K132211 SKAFFOLD NMX BONE VOID FILLER Skeletal Kinetics, LLC MQV Class II 2014-08-04
K141841 INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP Integra Lifescience Corportation MQV Class II 2014-08-01
K140302 OPTETRAK LOGIC POROUS FEMORAL COMPONENTS Exactech, Inc. MBH Class II 2014-07-30
K140883 VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT Biomet, Inc. MBH Class II 2014-07-30
K132912 DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT In2bones Sas HWC Class II 2014-07-30
K141001 ALPINE HIP STEM; ALPINE HA HIP STEM Ortho Development LPH Class II 2014-07-30
K133402 K2M MODULAR HOOKS K2m, Inc. NKB Class II 2014-07-30
K141011 G-FORCE GEN 2 SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 2014-07-30
K133840 Kangli Locking Plate System Suzhou Kangli Orthopaedics Instrument Co., Ltd. HRS Class II 2014-07-29
K140431 PEDILOC FRAGMENT SYSTEM OrthoPediatrics Corp. HRS Class II 2014-07-29
K133947 IRIX-A LUMBAR INTEGRATED FUSION SYSTEM X-Spine Systems, Inc. OVD Class II 2014-07-29
K141119 CAMERA ENABLED PROBE Trice Medical, Inc. HRX Class II 2014-07-29
K141797 ALTEON 6.5MM BONE SCREWS Exactech, Inc. LPH Class II 2014-07-29
K140479 COROENT XL-F SYSTEM Nu Vasive, Incorporated OVD Class II 2014-07-28
K140071 HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions KWT Class II 2014-07-28
K140921 COROENT SMALL INTERBODY SYSTEM Nu Vasive, Incorporated ODP Class II 2014-07-28
K140770 MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM Nu Vasive, Incorporated MAX Class II 2014-07-25
K132907 PLIF LITE AND TLIF LITE Sintea Plustek MAX Class II 2014-07-24
K141711 PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE Pontis Orthopaeeics, LLC MBI Class II 2014-07-24
K133906 C-JAWS CERVICAL COMPRESSIVE STAPLE Medicrea International PHQ Class II 2014-07-24
K141489 LINOS MOH HAND PLATING SYSTEM KLS Martin L.P. HRS Class II 2014-07-24
K141049 IFUSE IMPLANT SYSTEM SI-BONE, Inc. OUR Class II 2014-07-23
K141784 ORTHO SOLUTIONS ULTOS PLATING SYSTEM Ortho Solutions Limited HRS Class II 2014-07-23
K132820 VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES Vilex, Inc. JDW Class II 2014-07-23
K141284 CASPIAN SPINAL SYSTEM K2m, Inc. KWP Class II 2014-07-23
K140876 VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic HRS Class II 2014-07-22
K140864 VELOXTM INTERBODY FUSION SYSTEM U&I Corp. ODP Class II 2014-07-22
K133370 REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE Signature Orthopaedics Pty Limited LPH Class II 2014-07-22
K141677 VARIAX ELBOW PLATING SYSTEM Stryker Trauma AG HRS Class II 2014-07-22
K140879 BIOSURE HEALICOIL PK INTERFERENCE SCREW Smith & Nephew, Inc. MBI Class II 2014-07-21
K140915 EXCIA TOTAL HIP SYSTEM Aesculap Implant Systems, LLC LZO Class II 2014-07-21
K141577 ARTHREX PIP DART Arthrex, Inc. HTY Class II 2014-07-18
K141219 JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS Biomet Manufacturing Corp HTN Class II 2014-07-18
K140082 AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM Tornier S.A.S. PHX Class II 2014-07-18
K141430 VARIAX DISTAL RADIUS PLATING SYSTEM Stryker Leibinger GmbH & Co KG HRS Class II 2014-07-18
K132732 MEDYSSEY ANTERIOR CERVICAL FUSION CAGE Medyssey USA, Inc. ODP Class II 2014-07-18
K140903 NUVIS ARTHROSCOPE Integrated Endoscopy, Inc. HRX Class II 2014-07-17
K140750 SHILLA GROWTH GUIDANCE SYSTEM Medtronic Sofamor Danek USA, Inc. PGM Class II 2014-07-17
K140142 CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) Choicespine, LP MAX Class II 2014-07-16
K141217 ACCULIF TL AND PL CAGE Stryker Corporation MAX Class II 2014-07-16
K140844 BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC Synergy Biomedical, Inc. MQV Class II 2014-07-16
K133053 MILESTONE SPINAL SYSTEM Weigao Orthopaedic Device Co., Ltd. MAX Class II 2014-07-15
K133813 FLXFIT INTERVERTEBRAL BODY FUSION DEVICE Expanding Orthopedics, Inc. MAX Class II 2014-07-15
K140826 GMK SPHERE EXTENSION Medacta International JWH Class II 2014-07-15
K133919 CONSENSUS VITALITE TIBIAL INSERT Consensus Orthopedics, Inc. JWH Class II 2014-07-14
K132765 PFX SPINOUS PROCESS FIXATION SYSTEM Innovasis, Inc. PEK Class II 2014-07-14
K141605 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2014-07-14
K141550 INSTAFIX SHAPE MEMORY FIXATION SYSTEM Ot Medical JDR Class II 2014-07-11
K141301 MAXLOCK EXTREME ELBOW FRACTURE SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2014-07-11
K140830 EXPRT REVISION KNEE Encore Medical L.P. JWH Class II 2014-07-11
K140765 RANGE/MESA/DENALI SPINAL SYSTEM K2m, Inc. NKB Class II 2014-07-10
K140531 BIOFOAM BONE WEDGE Wrightmedicaltechnologyinc HRS Class II 2014-07-09
K141417 CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW Wrightmedicaltechnologyinc HRS Class II 2014-07-09
K140417 DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM Medtronic Sofamor Danek, Inc. KWQ Class II 2014-07-09
K141478 ARTHREX FRACTURE PLATES AND SCREWS Arthrex, Inc. HRS Class II 2014-07-08
K133811 RESTORIS POROUS PARTIAL KNEE SYSTEM Mako Surgical Corp. NJD Class II 2014-07-08
K140643 GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY Depuy Mitek, A Johnson and Johnson Company MAI Class II 2014-07-08
K141228 AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW Advanced Orthopaedic Solutions, Inc. HSB Class II 2014-07-08
K133784 VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION Zimmer Trabecular Metal Technology ODP Class II 2014-07-07
K140324 RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL Depuy Mitek, A Johnson and Johnson Company MBI Class II 2014-07-07
K140962 NORMED VARIO SUBTALAR SCREW Normed Nedizin Technik GmbH HWC Class II 2014-07-03
K133835 ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM Arthrosurface, Inc. HTN Class II 2014-07-03
K140902 E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG Biomet, Inc. JWH Class II 2014-07-03
K140652 POROUS COATED COMPREHENSIVE FRACTURE STEMS Biomet Manufacturing Corp PHX Class II 2014-07-03
K140260 SKYHAWK LATERAL PLATE SYSTEM Orthofix, Inc. KWQ Class II 2014-07-02
K140601 FLOW-NAIL Flow-Fx, LLC HSB Class II 2014-07-02
K140162 AP EXPANDABLE XLIF SYSTEM Nuvasive, Inc. MAX Class II 2014-07-02
K140055 ENDOSKELETON(R) TL INTERBODY FUSION DEVICE Titan Spine, LLC MAX Class II 2014-07-02
K133288 CASPIAN OCT SPINAL SYSTEM K2m, Inc. KWP Class II 2014-07-01
K140411 ALTERA SPACER Globus Medical, Inc. MAX Class II 2014-07-01
K140674 EXACTECH TAPERED WEDGE FEMORAL STEM Exactech, Inc. LZO Class II 2014-06-30
K141395 DELTA TT ACETABULAR SYSTEM Lima Corporate S.P.A. LPH Class II 2014-06-30
K133575 SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM Spinevision S.A. MNH Class II 2014-06-30
K141045 MBD PLATE SYSTEM Mbd Medical, LLC HRS Class II 2014-06-30
K140833 ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2014-06-30
K141447 PRECICE TRAUMA NAIL SYSTEM Ellipse Technologies, Inc. HSB Class II 2014-06-30
K140701 NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG Novosource, Inc. OQG Class II 2014-06-27
K141397 SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM Precision Spine, Inc. MNI Class II 2014-06-26
K141376 INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS Nexxt Spine, LLC MNH Class II 2014-06-26

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