meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
29
Latest Decision
2009-09-08

Clearances · page 87 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K091619 ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) Anglefix KTT Class II 2009-09-08
K090871 CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 Bonesupport AB MQV Class II 2009-09-04
K092375 MODIFICATION TO SI JOINT FUSION SYSTEM SI-BONE, Inc. OUR Class II 2009-09-04
K091406 ATLAS SPINE SPACER Atlas Spine, LLC MQP Class II 2009-09-04
K090315 STAXX XD SYSTEM Spine Wave, Inc. MQP Class II 2009-09-03
K091359 GSO PCT SPINAL SYSTEM Gold Standard Orthopaedics, LLC KWP Class II 2009-09-02
K091974 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2009-09-02
K091798 MERETE COMPRESSION SCREWS Merete Medical GmbH HWC Class II 2009-09-02
K092419 AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS Howmedica Osteonics Corp. HRS Class II 2009-09-01
K091844 ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS Arthrex, Inc. MAI Class II 2009-08-28
K090304 WAVEON WRX BONE FIXATION SYSTEM Sonoma Orthopedic Products, Inc. HRS Class II 2009-08-28
K083270 WMT COMPOSITE DBM Wrightmedicaltechnologyinc MQV Class II 2009-08-27
K091398 ARTHROSCOPE Orthopedic Sciences, Inc. HRX Class II 2009-08-26
K083582 SIGN HIP CONSTRUCT (SHC), MODEL: 701 Surgical Implant Generation Network (Sign) KTT Class II 2009-08-26
K091423 PROFEMUR HIP SYSTEM MODULAR NECKS Wrightmedicaltechnologyinc KWA Class III 2009-08-25
K092201 ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE Wrightmedicaltechnologyinc JWH Class II 2009-08-20
K091976 BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL Biomet Trauma HSB Class II 2009-08-17
K091134 CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE Custom Spine, Inc. KWQ Class II 2009-08-17
K090048 ASFORA BULLET CAGE SYSTEM Medical Designs, LLC MAX Class II 2009-08-14
K091763 MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 Instratek, Inc. HTN Class II 2009-08-14
K090740 MODIFICATION TO: TSRH SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2009-08-14
K092108 TRUSS THORACOLUMBAR PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2009-08-13
K091782 REVERE 6.35 STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2009-08-13
K091453 LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DePuy Orthopaedics, Inc. KRO Class II 2009-08-12
K090343 SENTINEL SPINAL SYSTEM Life Spine KWP Class II 2009-08-11
K091193 ACCELL EVO3C Isotis Orthobiologics, Inc. MBP Class II 2009-08-10
K091995 LAGUNA SIZE 8 PEDICLE SCREW SYSTEM Allez Spine, LLC NKB Class II 2009-08-07
K092073 MONOPOLY PEDICLE SCREW SYSTEM Signus Medical NKB Class II 2009-08-07
K091381 IBEX SPINAL SYSTEM Ebi, L.P. MAX Class II 2009-08-07
K091041 RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS Depuy Mitek, A Johnson & Johnson Company MAI Class II 2009-08-07
K090107 MINI TIGHTROPE Arthrex, Inc. HTN Class II 2009-08-06
K091365 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Soafamor Danek KWP Class II 2009-08-06
K091396 CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM Cardo Medical Corp. KWQ Class II 2009-08-05
K092078 OPTILOCK PERIARTICULAR PLATING Biomet Trauma HRS Class II 2009-08-05
K083707 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE Arthrex, Inc. HRX Class II 2009-08-03
K091944 MODIFICATION TO: DSS STABILIZATION SYSTEM Paradigm Spine, LLC NQP Class II 2009-08-03
K070385 TI-TAMED SPINAL SYSTEM Ti-Tamed (Pty), Ltd. NKB Class II 2009-07-31
K090949 SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS Synthes (Usa) HWC Class II 2009-07-31
K083810 PASS LP SPINAL SYSTEM Medicrea Technologies MNI Class II 2009-07-31
K091988 MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 Vertebral Technologies, Inc. MAX Class II 2009-07-30
K092015 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM Smith & Nephew, Inc. HRS Class II 2009-07-30
K091190 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 Zimmer Spine, Inc. JDQ Class II 2009-07-30
K090224 FORTEX PEDICLE SCREW SYSTEM X-Spine Systems, Inc. MNH Class II 2009-07-30
K090203 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS Ebi, L.P. NKB Class II 2009-07-30
K091788 PANTA NAIL (DIA. 10MM), PANTA NAIL XL Newdeal Sas HSB Class II 2009-07-29
K090477 ALPINE PEDICLE SCREW SYSTEM Sanacor MNH Class II 2009-07-27
K092122 GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID DePuy Orthopaedics, Inc. KWS Class II 2009-07-27
K091110 SPINAL EDGE TITAN PEDICLE SCREW SYSTEM Spinal Edge, LLC MNH Class II 2009-07-24
K082848 NUBIC AND RABEA DEVICES Signus Medizintechnik GmbH ODP Class II 2009-07-24
K091258 EXTRAFIX EXTERNAL FIXATION SYSTEM Qfx Technologies, Inc. KTT Class II 2009-07-24
K091294 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DePuy Orthopaedics, Inc. HRS Class II 2009-07-24
K091577 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM Extremity Medical, LLC HWC Class II 2009-07-24
K090320 CONQUEST SPINAL SYSTEM Life Spine NKB Class II 2009-07-22
K091058 ADKINS STRUT Biomet Microfixation, Inc. HRS Class II 2009-07-22
K091502 NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. NKB Class II 2009-07-22
K083912 TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS Treu-Instrumente GmbH HWC Class II 2009-07-15
K091442 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2009-07-15
K090707 TALOS INTERVERTEBRAL BODY FUSION DEVICE Meditech Advisors, LLC MAX Class II 2009-07-15
K091156 TRIMED STERILE PRODUCT TriMed, Inc. HRS Class II 2009-07-15
K091751 DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP DePuy Orthopaedics, Inc. KWS Class II 2009-07-14
K091088 LDR SPINE CERVICAL INTERBODY FUSION SYSTEM Ldr Spine USA ODP Class II 2009-07-14
K090857 VALOR ANKLE FUSION NAIL SYSTEM Wrightmedicaltechnologyinc HSB Class II 2009-07-14
K091067 5.5 POLARIS SPINAL SYSTEM Biomet Spine NKB Class II 2009-07-14
K091479 APTUS FOOT SYSTEM Medartis AG HRS Class II 2009-07-13
K083154 NEWDEAL HALLU LOCK PLATE SYSTEM Newdeal Sas HRS Class II 2009-07-10
K091689 SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM Synthes (Usa) KWP Class II 2009-07-10
K091159 SYNTHES ORACLE PLATE Synthes Spine KWQ Class II 2009-07-10
K090988 GMK TOTAL KNEE SYSTEM Medacta International S.A. JWH Class II 2009-07-10
K091219 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC NKB Class II 2009-07-09
K091044 SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM Spinal USA KWQ Class II 2009-07-09
K091189 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. MNI Class II 2009-07-08
K091694 MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) Tag Medical Products HWC Class II 2009-07-07
K090779 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. MNI Class II 2009-07-07
K090582 CALCANEAL FRACTURE PLATE SYSTEM Tornier, Inc. HRS Class II 2009-07-02
K083004 MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM Aesculap Implant Systems, Inc. NKB Class II 2009-07-02
K090981 MODIFICATION TO: NUVASIVE SPHERX SYSTEM Nuvasive, Inc. NKB Class II 2009-07-02
K090522 OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM Osteomed LP HRS Class II 2009-07-02
K090523 POLARIS SPINAL SYSTEM Ebi, L.P. NKB Class II 2009-07-01
K090211 INFLATABLE BONE TAMP Cardinal Health, Inc. NDN Class II 2009-07-01
K091587 MERCURY SPINAL SYSTEM Spinal Elements, Inc. NKB Class II 2009-07-01
K090983 APTUS 2.0/2.3 FOUR CORNER FUSION PLATE Medartis AG HRS Class II 2009-07-01
K090596 ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM Zimmer, Inc. HSB Class II 2009-06-30
K090984 INERTIA PEDICLE SCREW SYSTEM Nexxt Spine, LLC MNI Class II 2009-06-30
K091609 NEWDEAL COMPRESSION PLATE Newdeal Sas HRS Class II 2009-06-30
K090923 PARCUS GRAFT FIXATION SYSTEM Parcus Medical, LLC MBI Class II 2009-06-30
K090565 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM Globus Medical, Inc. KWP Class II 2009-06-30
K090877 PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DePuy Orthopaedics, Inc. HRS Class II 2009-06-26
K083435 ARTHREX UNIVERS II SHOULDER PEGGED GLENOID Arthrex, Inc. KWS Class II 2009-06-26
K091243 ORTHOLOC ANKLE PLATING SYSTEM (APS) Wrightmedicaltechnologyinc HRS Class II 2009-06-26
K090507 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM Ldr Spine USA MAX Class II 2009-06-25
K091291 XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD Stryker Spine NKB Class II 2009-06-24
K091549 CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM Linvatec Corp. MBI Class II 2009-06-23
K090835 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR Linvatec Corp. MAI Class II 2009-06-22
K090099 DSS STABILIZATION SYSTEM Paradigm Spine, LLC NKB Class II 2009-06-19
K090786 KENS INTERNAL FIXATION SYSTEM Kens Finemedtech Sdn. Bhd HRS Class II 2009-06-18
K090241 SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes (Usa) HSB Class II 2009-06-17
K091503 MAGNUM MP FIXATION DEVICE Arthrocare Corp. MBI Class II 2009-06-17
K090763 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM Mako Surgical Corporation NPJ Class II 2009-06-17
K083144 ACUMED CLAVICLE SCREW SYSTEM Acumed, LLC JDW Class II 2009-06-16
K091161 REJUVENATE MONOLITHIC SIZE 4 HIP STEM Howmedica Osteonics Corp. MEH Class II 2009-06-16

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