meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2013-12-19

Clearances · page 65 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133475 STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS Nexxt Spine, LLC KWQ Class II 2013-12-19
K132876 ARIX HAND LOCKING SYSTEM Jeil Medical Corporation HRS Class II 2013-12-18
K133460 APTUS CANNULATED COMPRESSION SCREWS Medartis AG HWC Class II 2013-12-18
K132878 M.U.S.T. EXTENSION Medacta International NKB Class II 2013-12-18
K133440 AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION Stryker Trauma AG HWC Class II 2013-12-18
K132218 PERFIX ILIAC SCREW SYSTEM U&I Corporation MNH Class II 2013-12-17
K133246 ZIMMER DISTAL RADIUS PLATING SYSTEM Zimmer, Inc. HRS Class II 2013-12-17
K133291 ST360 DEGREES SPINAL FIXATION SYSTEM Zimmer Spine, Inc. NKB Class II 2013-12-17
K133188 MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL Stryker Spine NKB Class II 2013-12-17
K130652 VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT Consensus Orthopedics, Inc. OQG Class II 2013-12-17
K133342 ARTHREX IBALANCE TKA SYSTEM Arthrex, Inc. JWH Class II 2013-12-17
K132910 DEPUY SYNTHES SPINE DENS ACCESS SYSTEM Synthes USA Products, LLC HWC Class II 2013-12-16
K130073 MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS Mikron Makina Sanayi VE Ticaret Ltd. Sti. MNI Class II 2013-12-16
K131952 CORIN METAFIX HIP STEM Corin USA LZO Class II 2013-12-16
K131986 CORIN MINIHIP STEM Corin USA LZO Class II 2013-12-16
K130913 GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM Genesys Spine MAX Class II 2013-12-13
K132594 CROSSCHECK PLATING SYSTEM Solana Surgical, LLC HRS Class II 2013-12-13
K133035 NORMED PELLEGRIN CALCANEUS STOP SCREW Normed Medizin-Technik GmbH HWC Class II 2013-12-13
K132873 VANGUARD XP KNEE SYSTEM Biomet, Inc. MBH Class II 2013-12-11
K132897 CLYDESDALE SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MAX Class II 2013-12-11
K130317 GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM Genesys Spine ODP Class II 2013-12-11
K133094 CERTEX OCT SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. KWP Class II 2013-12-11
K130708 SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS Smith & Nephew, Inc. JWH Class II 2013-12-11
K133039 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM Mako Surgical Corporation NPJ Class II 2013-12-10
K133289 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2013-12-09
K132783 EXOSHAPE DUO SOFT TISSUE FASTENER MedShape, Inc. MBI Class II 2013-12-09
K133126 K7 LUMBAR SPACERS K7, LLC MAX Class II 2013-12-09
K133372 CROSSTREES PVA POD Crosstrees Medical, Inc. NDN Class II 2013-12-06
K133207 STAXX(R) SYSTEM Spine Wave, Inc. MQP Class II 2013-12-06
K132395 LIGAPASS Medicrea International OWI Class II 2013-12-06
K132328 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2013-12-06
K132640 IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. HSX Class II 2013-12-05
K132285 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier S.A.S. PHX Class II 2013-12-05
K133376 AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT Tornier, Inc. HSB Class II 2013-12-05
K132994 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM Corelink, LLC KWQ Class II 2013-12-05
K130467 POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE MedShape, Inc. MBI Class II 2013-12-05
K132584 PERIMETER C SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. ODP Class II 2013-12-04
K133437 1ST MTP PLATE Osteomed HRS Class II 2013-12-02
K132848 PIEZOSURGERY FLEX Mectron S.P.A. JDX Class II 2013-11-29
K133086 TITLE 2 POLYAXIAL SPINAL SYSTEM Zimmer Spine, Inc. NKB Class II 2013-11-27
K131591 FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) Pega Medical, Inc. HWC Class II 2013-11-27
K133091 ZIP MIS INTERSPINOUS FUSION SYSTEM Aurora Spine PEK Class II 2013-11-27
K133061 ESPIN SYSTEM Nlt Spine, Ltd. HRX Class II 2013-11-27
K131025 ARCHON ANTERIOR CERVICAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2013-11-27
K131298 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM Exactech, Inc. HSD Class II 2013-11-26
K132740 SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM Spinefrontier, Inc. NQW Class II 2013-11-26
K132624 TRIATHLON TRITANIUM METAL-BACKED PATELLA Stryker Orthopaedics MBH Class II 2013-11-26
K132217 ARTHREX COMPRESSION FT SCREWS Arthrex, Inc. HWC Class II 2013-11-25
K132029 VAULT-C INTERVERTEBRAL BODY FUSION DEVICE Spinal USA OVE Class II 2013-11-25
K132884 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Zimmer Spine, Inc. NKB Class II 2013-11-25
K132639 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2013-11-25
K132101 ANAX 5.5 SPINAL SYSTEM U&I Corporation MNH Class II 2013-11-25
K132504 TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM Corelink, LLC KWP Class II 2013-11-25
K133216 CRESCENT SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MAX Class II 2013-11-22
K132191 SP-FIX SPINOUS PROCESS FIXATION PLATE Globus Medical, Inc. PEK Class II 2013-11-22
K132893 EDGE ORTHOPAEDICS BITE COMPRESSION SCREW Icon Orthopaedic Concepts Dba Edge Orthopaedics HWC Class II 2013-11-20
K132757 EVEREST SPINAL SYSTEM K2m, Inc. MNI Class II 2013-11-20
K132603 APEX SPINE SYSTEM Spinecraft, LLC NKB Class II 2013-11-20
K132411 AFFIX II SPINOUS PROCESS PLATE SYSTEM Nu Vasive, Incorporated PEK Class II 2013-11-20
K131377 HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. KWD Class II 2013-11-19
K132898 A.L.P.S. CALCANEAL PLATING SYSTEM Biomet Manufacturing Corp HRS Class II 2013-11-19
K132968 UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) Stryker Spine PEK Class II 2013-11-18
K133102 FLOWER ANKLE PLATING SET Flower Orthopedics Corporation HRS Class II 2013-11-18
K132718 INTEGRITY SPINE CORE SYSTEM Integrity Spine ODP Class II 2013-11-18
K131782 LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 Aap Implantate AG HRS Class II 2013-11-18
K131850 TENSYN BAND Dallen Medical, Inc. HTN Class II 2013-11-15
K130853 IDYS(TM) C Clariance ODP Class II 2013-11-13
K130066 SPECTRUM SPINE SPINOUS PROCESS DEVICE Spectrum Spine IP Holdings, LLC PEK Class II 2013-11-12
K131533 CAYMAN MI PLATE SYSTEM K2m, Inc. KWQ Class II 2013-11-09
K130759 HUMELOCK II CEMENTLESS SHOULDER SYSTEM Fx Solutions HSD Class II 2013-11-09
K132574 PASS LP SPINAL SYSTEM Medicrea International OSH Class II 2013-11-08
K132241 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T Depuy Mitek, A Johnson & Johnson Company MAI Class II 2013-11-05
K131834 WOLF LONG BONE PLATE SYSTEM Toby Orthopaedics HRS Class II 2013-11-04
K131518 MECTACER BIOLOX OPTION HEADS Medacta International LZO Class II 2013-11-04
K131566 ARIX HAND SYSTEM Jeil Medical Corporation HRS Class II 2013-11-04
K132883 HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) Hemodia Sas HRX Class II 2013-11-01
K131669 PERIMETER INTERBODY FUSION DEVICE Medtronic Sofamor Danek USA, Inc. MAX Class II 2013-11-01
K132280 ALTUS SPINE PEDICLE SCREW SYSTEM Altus Partners MNI Class II 2013-10-31
K132014 GSB GLOBAL SPINAL BALANCE SYSTEM Nuvasive, Inc. NKB Class II 2013-10-31
K122783 PLASMAFIT ACETABULAR CUP AND VITELENE INSERT Aesculap Implant System, Inc. OQG Class II 2013-10-30
K130675 ARTHREX UNIVERS II CA HEADS Arthrex, Inc. HSD Class II 2013-10-30
K132248 FLOWER BONE SCREW SET Flower Orthopedics Corporation HWC Class II 2013-10-30
K131116 U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER United Orthopedic Corporation JWH Class II 2013-10-30
K131867 2.5MM INLINE FUSION PLATE Biomet, Inc. HRS Class II 2013-10-29
K130048 REVERSE SHOULDER PROSTHESIS MONOBLOCK Encore Medical L.P. KWS Class II 2013-10-29
K130274 BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM Elite Surgical Supplies (Pty), Ltd. MAX Class II 2013-10-29
K132866 NAUTILUS SPINAL SYSTEM Life Spine, Inc. NKB Class II 2013-10-28
K132900 MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM Intelligent Implant Systems, LLC KWP Class II 2013-10-25
K131427 LOTUS Spinal Elements, Inc. KWP Class II 2013-10-24
K132510 BIOPRO - INFINITY PLATE ANCHOR SYSTEM Biopro, Inc. HTN Class II 2013-10-24
K131393 MAK OSS FEMORAL KNEE COMPONENTS Biomet Orthopedics Corp. KRO Class II 2013-10-24
K131679 EVOLUTION MP ADAPTIVE PS TIBIAL INSERT Wrightmedicaltechnologyinc JWH Class II 2013-10-23
K132895 WMT IMPLANTABLE K-WIRE Wrightmedicaltechnologyinc HTY Class II 2013-10-23
K131350 CALIX LUMBAR SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. MAX Class II 2013-10-23
K132502 VARIAX 2 SYSTEM Stryker Trauma AG HRS Class II 2013-10-23
K132435 SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS Smith & Nephew, Inc. LZO Class II 2013-10-22
K131187 LESSER METATARSAL HEAD IMPLANT SYSTEM Solana Surgical, LLC KWD Class II 2013-10-22
K122437 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS Biomet Sports Medicine MBI Class II 2013-10-18
K131459 AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE Aap Implantate AG JDW Class II 2013-10-17
K130958 TRUE SPINAL FIXATION SYSTEM Innovative Surgical Designs MNI Class II 2013-10-17

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