meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2014-02-27

Clearances · page 64 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133854 ARTHREX IBALANCE TKA SYSTEM Arthrex, Inc. JWH Class II 2014-02-27
K133018 OSI Q SYSTEM ARTHROSCOPES Orthopedic Sciences, Inc. HRX Class II 2014-02-26
K133536 EMERGE MEDICAL BONE PLATE SYSTEM Emerge Medical HRS Class II 2014-02-26
K133287 PRESSON SPINAL FIXATION SYSTEM Nexus Spine, LLC MNH Class II 2014-02-25
K133162 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA Materialise NV JWH Class II 2014-02-25
K133904 CD HORIZON SPINAL SYSTEM GROWTH ROD SET Medtronic Sofamor Danek USA PGM Class II 2014-02-25
K133691 EXTRIMILOCK ANKLE PLATING SYSTEM Osteomed LP HRS Class II 2014-02-24
K131481 FREEDOM PCK COMPONENTS Maxx Orthopedics, Inc. JWH Class II 2014-02-21
K132158 NOVOHIP TOTAL HIP SYSTEM Novosource, Inc. LPH Class II 2014-02-21
K133585 INBONE TOTAL ANKLE Wrightmedicaltechnologyinc HSN Class II 2014-02-20
K133567 UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2014-02-20
K133617 JAZZ SYSTEM Implanet, S.A. OWI Class II 2014-02-20
K133564 MODIFICATION TO NAUTILUS SPINAL SYSTEM Life Spine, LLC NKB Class II 2014-02-19
K133449 KASM KNEE ARTICULATING SPACER MOLDS Ortho Development Corp. JWH Class II 2014-02-18
K132582 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM Exactech, Inc. OVE Class II 2014-02-12
K131552 CONVENTUS DRS Conventus Orthopaedics HRS Class II 2014-02-12
K131454 KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD Total Joint Orthopedics, Inc. LPH Class II 2014-02-12
K132991 C-BOX PEEK CERVICAL IBF Innovasis, Inc. ODP Class II 2014-02-12
K132925 SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK Amendia, Inc. NKB Class II 2014-02-11
K140063 EQUINOXE EXTRA SHORT HUMERAL HEAD Exactech, Inc. KWS Class II 2014-02-11
K133477 TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS Synchro Medical HTY Class II 2014-02-10
K133623 C-PLUS Pioneer Surgical Technology, Inc. ODP Class II 2014-02-10
K133583 OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 Interventional Spine, Inc. MAX Class II 2014-02-10
K132050 NB3D BONE VOID FILLER Pioneer Surgical Technology, Inc. MQV Class II 2014-02-07
K133462 DUOCENTRIC REVERSED SHOULDER PROSTHESIS Aston Medical KWS Class II 2014-02-07
K132539 RING-LOK MODULAR BIPOLAR SYSTEM Implants International, Ltd. KWY Class II 2014-02-07
K133523 STAPIX SUPERELASTIC IMPLANT BONE STAPLES Instratek, Inc. JDR Class II 2014-02-06
K133757 GFS II STANDARD, GFS II LARGE, GFS MIMI Parcus Medical, LLC MBI Class II 2014-02-04
K132886 SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM Smith & Nephew, Inc. HRS Class II 2014-02-04
K133737 ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION Zimmer, Inc. JWH Class II 2014-02-04
K133794 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 Depuy Mitek, A Johnson & Johnson Company MAI Class II 2014-02-04
K131292 DEROYAL SPINE SPACER SYSTEM Deroyal Industries, Inc. MAX Class II 2014-02-03
K133557 JULIET LL LATERAL LUMBAR CAGE Spineart MAX Class II 2014-02-03
K133967 INTERBODY CAGE SYSTEM Aurora Spine MAX Class II 2014-01-31
K133184 ARDIS INTERBODY SYSTEM Zimmer Spine, Inc. MAX Class II 2014-01-30
K133229 TITANIUM SUTURE ANCHOR Mtp Solutions, LLC MBI Class II 2014-01-30
K131833 CENTURION POCT SYSTEM Orthofix, Inc. KWP Class II 2014-01-30
K133275 MINI TIGHTROPE Arthrex, Inc. HTN Class II 2014-01-30
K133192 MECTALIF TIPEEK Medacta International MAX Class II 2014-01-30
K133541 EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM Emerge Medical HRS Class II 2014-01-28
K131413 XTRAFIX SMALL EXTERNAL FIXATION SYSTEM Zimmer, Inc. KTT Class II 2014-01-28
K133103 AVERSION PEDICLE SCREW SYSTEM K7, LLC MNI Class II 2014-01-27
K133785 TRITIUM STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc. JDQ Class II 2014-01-27
K133354 PERI-PROSTHETIC CABLE SYSTEM Biomet, Inc. JDQ Class II 2014-01-27
K132817 KIVA VCF TREATMENT SYSTEM Benvenue Medical, Inc. NDN Class II 2014-01-24
K133675 AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 Aap Implantate AG HRS Class II 2014-01-23
K131490 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2014-01-23
K133152 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT Stanmore Implants Worldwide , Ltd. KRO Class II 2014-01-22
K131135 BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS Biomet Manufacturing Corp MBB Class II 2014-01-22
K132122 KESTREL POSTERIOR CERVICAL SPINE SYSTEM Omni Surgical, LLC Dba Spine360 KWP Class II 2014-01-22
K133950 ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) Bioretec, Ltd. HTY Class II 2014-01-22
K132879 MPACT EXTENSION Medacta International LPH Class II 2014-01-22
K132421 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM Aesculap Implant Systems, Inc. MAX Class II 2014-01-22
K130613 CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM Laura Cattabriga HWC Class II 2014-01-22
K133228 ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM Iconacy Orthopedic Implants, LLC LPH Class II 2014-01-17
K130614 BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS Laura Cattabriga HRS Class II 2014-01-17
K133698 SYNAPSE SYSTEM Synthes USA Products, LLC KWP Class II 2014-01-16
K133164 DYNESYS TOP-LOADING SPINAL SYSTEM Zimmer Spine, Inc. NQP Class II 2014-01-16
K133727 Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU ArthroCare Corporation MBI Class II 2014-01-16
K132894 OPTIO-C ANTERIOR CERVICAL SYSTEM Zimmer Spine, Inc. OVE Class II 2014-01-16
K132363 DOLPHIX EXTERNAL FIXATION SYSTEM Citieffe S.R.L. KTT Class II 2014-01-16
K131864 U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT United Orthopedic Corporation JWH Class II 2014-01-15
K133369 TIGER SPINE SYSTEM Corelink, LLC NKB Class II 2014-01-14
K123758 TASMIN R Signus Medizintechnik GmbH MQP Class II 2014-01-14
K133063 SANTIS PEDICLE SCREW SYSTEM Lanterna Medical Technologies NKB Class II 2014-01-13
K133066 SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM Spineselect, LLC NKB Class II 2014-01-13
K132731 DIGIFIX EXTERNAL FIXATION SYSTEM Virak Orthopedic Research, LLC JEC Class II 2014-01-10
K132403 ANNEXTM ADJACENT LEVEL SYSTEM Spine Wave, Inc. MNH Class II 2014-01-10
K132071 BIOACTIVE BONE GRAFT PUTTY Biostructures, LLC MQV Class II 2014-01-10
K133286 MIDLINE (TM) Centinel Spine, Inc. OVD Class II 2014-01-09
K133321 ALAMO C Alliance Partners, LLC ODP Class II 2014-01-09
K133520 HAMMERLOCK 2 Biomedical Enterprises, Inc. HTY Class II 2014-01-09
K133371 RAMPART-L Spineology, Inc. MAX Class II 2014-01-09
K133256 ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM Conformis, Inc. JWH Class II 2014-01-09
K133452 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM Emerge Medical HRS Class II 2014-01-08
K132296 D-RAD SMART PACK Smith & Nephew, Inc. HRS Class II 2014-01-07
K132735 AXIA RADIAL HEAD SYSTEM Imds (Innovative MEdical Device Systems) - Leis ME KWI Class II 2014-01-07
K132769 ACUMED HAND PLATING SYSTEM Acumed, LLC HRS Class II 2014-01-06
K132830 DISTALOCK TIBIAL IM NAIL SYSTEM Dgimed Ortho, Inc. HSB Class II 2014-01-06
K131276 LATERAL SYNFIX Synthes (USA) Products, LLC OVD Class II 2014-01-06
K131880 SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM Spinefrontier, Inc. OVE Class II 2014-01-03
K133224 Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES Conmed Corporation MBI Class II 2014-01-03
K133645 PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2014-01-03
K132733 ORTHOHELIX SYNDESMOSIS FIXATION DEVICES Orthohelix Surgical Designs, Inc. HTN Class II 2014-01-03
K133081 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N Advanced Orthopaedic Solutions, Inc. HSB Class II 2013-12-31
K132875 COMPRESSYN STAPLE Dallen Medical, Inc. JDR Class II 2013-12-30
K132559 MONUMENT SPACERS Globus Medical, Inc. OVD Class II 2013-12-30
K132867 SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM Cayenne Medical, Inc. MBI Class II 2013-12-30
K130895 REUNION RSA SHOULDER SYSTEM Howmedica Osteonics Corp. PHX Class II 2013-12-27
K132601 COROENT STERILE IMPLANTS SYSTEM Nu Vasive, Incorporated MAX Class II 2013-12-24
K132787 LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE Aap Implantate AG HRS Class II 2013-12-24
K130977 SIGNIFY BIOACTIVE Globus Medical, Inc. MQV Class II 2013-12-24
K131724 PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE Pioneer Surgical Technology, Inc. MQP Class II 2013-12-24
K131521 VELOX ANTERIOR CERVICAL PLATE SYSTEM Spinecraft, LLC KWQ Class II 2013-12-24
K132310 ASCOT Backroads Consulting, Inc. KWQ Class II 2013-12-23
K133630 GMK SHORT STEM Medacta International JWH Class II 2013-12-20
K132790 INFIX ANTERIOR LUMBAR SYSTEM Zimmer Spine, Inc. MAX Class II 2013-12-20
K132428 IDEAL Jiangsu Ideal Medical Science & Technology Co., LT HSB Class II 2013-12-20
K133052 AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM Nuvasive, Inc. PEK Class II 2013-12-20
K133650 CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2013-12-20

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