meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2014-10-29

Clearances · page 60 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K142050 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM Nu Vasive, Incorporated ODP Class II 2014-10-29
K141912 AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON Advanced Orthopaedic Solutions, Inc. KTT Class II 2014-10-29
K142090 REBOSSIS Orthorebirth Co., Ltd. MQV Class II 2014-10-29
K142150 AIS MODULIFT VBR SYSTEM Aesculap Implant System, Inc. MQP Class II 2014-10-29
K142053 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM Zimmer Spine, Inc. OWI Class II 2014-10-29
K141850 FLOSPINE PEDICLE SCREW SYSTEM Flospine NKB Class II 2014-10-27
K142847 CD HORIZON Spinal System Medtronic Sofamor Danck USA, Inc. NKB Class II 2014-10-27
K141331 BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) Biomet, Inc. JDI Class II 2014-10-27
K142114 Xia® Growth Rod Conversion Set Stryker Corporation PGM Class II 2014-10-27
K141953 ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Titan Spine, LLC MAX Class II 2014-10-27
K141407 VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL Biomet, Inc. MBH Class II 2014-10-27
K142574 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, Depuy Mitek, A Johnson & Johnson Company MBI Class II 2014-10-24
K142727 CrossCLIP Implant System Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems JDR Class II 2014-10-24
K141714 PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM Wrightmedicaltechnologyinc HTY Class II 2014-10-24
K142079 STALIF CTI, STALIF C Centinel Spine, Inc. OVE Class II 2014-10-24
K142101 ABACUS (TM) SPACER SYSTEM Spine Wave, Inc. MAX Class II 2014-10-23
K142579 Zimmer Periarticular Plating System Zimmer, Inc. HRS Class II 2014-10-22
K142281 ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM Zimmer, Inc. HSB Class II 2014-10-22
K142602 VALOR Hindfoot Fusion Nail System Wrightmedicaltechnologyinc HSB Class II 2014-10-22
K142381 Xia 3 Spinal System Stryker Corp. NKB Class II 2014-10-21
K141604 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2014-10-21
K142026 SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. ODP Class II 2014-10-20
K140236 AILERON INTERSPINOUS FIXATION SYSTEM Life Spine, Inc. PEK Class II 2014-10-20
K141600 NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT Pioneer Surgical Technology, Inc. (Rti Surgical, I MQV Class II 2014-10-17
K142589 Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL Titan Spine, LLC MAX Class II 2014-10-17
K142653 G-Lok and G-Lok XL Extender T.A.G. Medical Products Corporation, Ltd. MBI Class II 2014-10-16
K142095 RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. OVD Class II 2014-10-15
K142193 COGENT MED-LIF XL Cogent Spine, LLC MAX Class II 2014-10-15
K142277 JULIET PO Spineart MAX Class II 2014-10-14
K140463 INTEGRA EXTERNAL FIXATION SYSTEM Ascension Orthopedic KTT Class II 2014-10-10
K141106 FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM Folsom Metal Products, Inc. Dba Frontier Devices OUR Class II 2014-10-10
K141791 BIOMET FUSION SYSTEM Biomet Spine OVD Class II 2014-10-09
K140319 COROENT TI-C SYSTEM Nuvasive, Inc. MAX Class II 2014-10-09
K141972 KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY Total Joint Orthopedics, Inc. OQG Class II 2014-10-09
K133245 GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM Genesys Spine KWQ Class II 2014-10-08
K141326 NEEDLE VIEW CH SCOPE KITS Biovision Technologies, LLC HRX Class II 2014-10-08
K141739 RESIDUAL LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2014-10-07
K142442 MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM Zimmer, Inc. HWC Class II 2014-10-03
K142534 HyProCure II Graham Medical Technologies, LLC Dba Gramedica HWC Class II 2014-10-03
K141347 EMERGE MEDICAL IM NAIL SYSTEM Emerge Medical HSB Class II 2014-10-02
K142450 DIVERGENCE Anterior Cervical Fusion System Medtronic Sofamor Danek USA, Inc. ODP Class II 2014-10-01
K142460 EXPEDIUM Spine System/Synapse System Johnson and Johnson KWP Class II 2014-10-01
K140577 INNESIS PEEK TL CAGE Bk Meditech, Co., Ltd. MAX Class II 2014-10-01
K141314 SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION Spineart OVE Class II 2014-09-29
K141290 HELICAL RIDGE PEEK INTERFERENCE SCREW MedShape, Inc. HWC Class II 2014-09-29
K141905 PRO-LINK WEDGE SYSTEM Life Spine HRS Class II 2014-09-26
K133577 CLYDESDALE(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2014-09-26
K142418 I.T.S. Hand Locking Plates System - HLS I.T.S. GmbH HRS Class II 2014-09-26
K141897 SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM Synthes USA Products, LLC KWP Class II 2014-09-25
K141804 POLARIS SPINAL SYSTEM - HA COATED Biomet Spine, LLC NKB Class II 2014-09-25
K142112 4WEB SPINAL IMPLANT PRODUCTS 4Web, Inc. MAX Class II 2014-09-23
K141103 INTRAMEDULLARY NAIL AND SCREWS-NEONAIL Neoortho Produtos Ortopedicos S/A HSB Class II 2014-09-23
K141500 OPTIO-C ANTERIOR CERVICAL SYSTEM Zimmer Spine, Inc. KWQ Class II 2014-09-23
K133717 LONGBOW SPACER SYSTEM Life Spine MAX Class II 2014-09-19
K141697 XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM Zimmer, Inc. KTT Class II 2014-09-18
K140613 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Ellipse Technologies, Inc. PGN Class II 2014-09-18
K141405 MOBIS II ST SPINAL IMPLANT Signus Medizintechnik GmbH MAX Class II 2014-09-16
K142306 Flower Upper Extremity Plating Set Flower Orthopedics Corporation HRS Class II 2014-09-15
K142295 Sirius Femoral Stem, Size 30A Biomet, Inc. JDI Class II 2014-09-15
K141419 ZVPLASTY Zavation, LLC NDN Class II 2014-09-12
K141949 CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM Aap Implantate AG HWC Class II 2014-09-12
K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. LZO Class II 2014-09-12
K142134 C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES Conmed Corporation, Largo HTY Class II 2014-09-12
K142230 Apollo Suture Anchor System and Titan Screws Valeris Medical MBI Class II 2014-09-10
K140390 TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS Biomet Manufacturing Corp MBF Class II 2014-09-10
K142213 VIA SPINOUS PROCESS FIXATION SYSTEM Spineology, Inc. PEK Class II 2014-09-10
K141937 TRIDENT FUSION IMPLANT Vilex IN Tennessee, Inc. HWC Class II 2014-09-10
K141835 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS Spineart MNI Class II 2014-09-10
K141337 ARENA-C Spinefrontier, Inc. ODP Class II 2014-09-08
K141873 RANGE/MESA/DENALI SPINAL SYSTEM K2m, Inc. NKB Class II 2014-09-08
K142157 PALACOS R+G PRO Heraeus Medical GmbH LOD Class II 2014-09-05
K140280 FORTICORE Nanovis, LLC ODP Class II 2014-09-05
K141824 MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP Medtronic Sofamor Danek, Inc. MQV Class II 2014-09-05
K140786 XENCO MEDICAL CERVICAL INTERBODY SYSTEM Xenco Medical, LLC ODP Class II 2014-09-03
K141635 ARTHREX IBALANCE TKA SYSTEM Arthrex, Inc. MBH Class II 2014-09-03
K133911 GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM Genesys Spine KWQ Class II 2014-09-03
K141840 TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH Zimmer, Inc. MBH Class II 2014-09-03
K134011 GENERAL SPINAL SYSTEM Changzhou Dean Medical Instrument Co, Ltd. MNH Class II 2014-09-03
K141078 ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) Orthofix Srl KTT Class II 2014-09-02
K141370 RENOVIS CEMENTED HIP SYSTEM Renovis Surgical Technologies, Inc. JDI Class II 2014-09-02
K141796 DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM Synthes (USA) Products, LLC HRS Class II 2014-08-29
K140735 EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS Microport Orthopedics, Inc. MBH Class II 2014-08-29
K142135 REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic HRS Class II 2014-08-28
K141821 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET Exactech, Inc. LZO Class II 2014-08-28
K141443 INFRONT LUMBAR INTERBODY FUSION SYSTEM Infront Medical, LLC MAX Class II 2014-08-28
K140892 DISTAL ELBOW PLATING SYSTEM Skeletal Dynamics, LLC HRS Class II 2014-08-28
K141291 VERTIFORM POSTERIOR FIXATION SYSTEM Next Orthosurgical NKB Class II 2014-08-26
K133678 CONFIRM BIOACTIVE Globus Medical, Inc. MQV Class II 2014-08-26
K140550 ORTHOHUB EXTERNAL FIXATOR SOFTWARE Orthohub, Inc. OSN Class II 2014-08-25
K141372 MERCURY SPINAL SYSTEM Spinal Elements, Inc. NKB Class II 2014-08-22
K141509 ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS Medos Sarl PGM Class II 2014-08-22
K140946 NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE Novabone Products, LLC MQV Class II 2014-08-22
K141930 OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML Osseon, LLC NDN Class II 2014-08-21
K141508 ROMEO 2 PAD POSTERIOR AXIAL DEVICE Spineart PEK Class II 2014-08-21
K142121 VALOR HINDFOOT FUSION NAIL SYSTEM Wrightmedicaltechnologyinc HRS Class II 2014-08-21
K141585 SMITH & NEPHEW DISPOSABLE FIN PUNCH Smith & Nephew, Inc. JWH Class II 2014-08-21
K142148 ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. JDR Class II 2014-08-21
K141004 INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. HTY Class II 2014-08-21
K141264 TENSYN BAND, TENSYN FRACTURE PLATES Dallen Medical, Inc. HTN Class II 2014-08-21
K141988 M.U.S.T PEDICLE SCREW SYSTEM Medacta International NKB Class II 2014-08-19

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