meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2012-02-24

Clearances · page 75 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112861 SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM Sintea Plustek, LLC KWQ Class II 2012-02-24
K111970 KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT Tornier KRR Class II 2012-02-23
K120163 ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM Acute Innovations, LLC HRS Class II 2012-02-17
K120155 ARTHREX KNOTLESS SUTURETAK ANCHOR Arthrex, Inc. MBI Class II 2012-02-17
K113452 ACU-CUT VERTEBRAL AUGMENTATION SYSTEM Ascendx Spine, Inc. NDN Class II 2012-02-17
K113556 WAGNER CONE PROSTHESIS SYSTEM Zimmer GmbH LZO Class II 2012-02-17
K113518 ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Spinefrontier, Inc. ODP Class II 2012-02-16
K110404 EAUM TOTAL KNEE SYSTEM Corentec Co., Ltd. JWH Class II 2012-02-16
K120143 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL Apollo Spine ODP Class II 2012-02-16
K111448 ICON (TM) MODULAR PEDICLE SCREW SYSTEM Orthofix, Inc. NKB Class II 2012-02-16
K120121 COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE Biomet, Inc. PHX Class II 2012-02-16
K113378 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2012-02-15
K120140 FOCUS SPINAL SYSTEM L&K BIOMED Co., Ltd. NKB Class II 2012-02-15
K113409 S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL Howmedica Osteonics Corp. HSB Class II 2012-02-15
K111018 POLYFUSE - NEUROBONE Atpac Medical, LLC MQV Class II 2012-02-14
K112595 COFLEX-F Paradigm Spine, LLC KWP Class II 2012-02-13
K113362 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) Spine View, Inc. HRX Class II 2012-02-10
K113529 CD HORIZON VOYAGER SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2012-02-09
K113396 DEPUY PULSE THORACOLUMBAR SCREW SYSTEM Medos International SARL NKB Class II 2012-02-08
K120083 SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) Synthes USA HSB Class II 2012-02-08
K111678 ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS Ortho Solutions Limited HRS Class II 2012-02-07
K112383 CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER Skeletal Kinetics, LLC MQV Class II 2012-02-07
K111481 CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS Corin USA OQI Class II 2012-02-06
K113752 METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET Solana Surgical, LLC KWD Class II 2012-02-06
K111726 PATHWAY AVID Custom Spine, Inc. MAX Class II 2012-02-06
K113642 PERIMETER INTERBODY FUSION DEVICE Medtronic Sofamor Danek USA MAX Class II 2012-02-06
K113762 CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM Arthrosurface, Inc. HRS Class II 2012-02-06
K120029 HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET Solana Surgical, LLC KWD Class II 2012-02-06
K113322 CONSERVE THIN SHELL Wrightmedicaltechnologyinc KWA Class III 2012-02-03
K120047 CORAL SPINAL SYSTEM Theken Spine, LLC NKB Class II 2012-02-03
K120068 CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) Conformis, Inc. JWH Class II 2012-02-03
K113755 SAVANNAH TECHNOLOGIES SPINAL SYSTEM Savannah Technologies, LLC MNI Class II 2012-02-01
K112906 KLASSIC KNEE SYSTEM Total Joint Orthopedics, Inc. JWH Class II 2012-02-01
K113149 SYNTHES USS CONNECTORS Synthes Spine MNI Class II 2012-02-01
K112736 PASS LP SPINAL Medicrea International JDQ Class II 2012-02-01
K113014 CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS Wrightmedicaltechnologyinc HRS Class II 2012-01-31
K112526 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS Smith & Nephew, Inc. MBI Class II 2012-01-31
K113048 MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2012-01-30
K111294 SANTORINI SPINAL SYSTEM K2m, Inc. MQP Class II 2012-01-27
K113571 GMK RESUFACING PATELLA SIZE 4 Medacta International JWH Class II 2012-01-27
K113718 NCB STRAIGHT NARROW SHAFT PLATES Zimmer GmbH HRS Class II 2012-01-27
K113030 SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. MAX Class II 2012-01-26
K111232 GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc. HSB Class II 2012-01-26
K111786 HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM Stryker Corp. KTT Class II 2012-01-26
K113447 RISE SPACER Globus Medical, Inc. MAX Class II 2012-01-26
K112429 GIZA(R) VERTEBRAL BODY REPLACEMENT Eden Spine, LLC MQP Class II 2012-01-26
K113218 PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM Pioneer Surgical Technology, Inc. NQW Class II 2012-01-26
K111634 XENON(TM) PEDICLE SCREW SYSTEM Alphatec Spine, Inc. NKB Class II 2012-01-25
K112206 CARDIFF ANTERIOR CERVICAL PLATE SYSTEM Seaspine, Inc. KWQ Class II 2012-01-25
K113154 IVAS BALLOON CATHETER Stryker Corporation NDN Class II 2012-01-24
K113167 MTF NEW BONE VOILD FILLER Musculoskeletal Transplant Foundation MQV Class II 2012-01-24
K111971 SYNDE-LOCK SYNDESMOSIS REPAIR KIT Tarsus Medical, Inc. HWC Class II 2012-01-23
K113527 OPTICAGE INTERBODY FUSION DEVICE Interventional Spine, Inc. MAX Class II 2012-01-20
K110896 RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC MNI Class II 2012-01-20
K113509 LEXUS ANTERIOR CERVICAL PLATE SYSTEM L&K BIOMED Co., Ltd. KWQ Class II 2012-01-20
K113294 SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR Smith & Nephew, Inc. MBI Class II 2012-01-20
K113173 NANOVIS SPINAL SYSTEM Nanovis, LLC NKB Class II 2012-01-19
K111719 OASYS SPINAL SYSTEM Stryker Spine KWP Class II 2012-01-19
K113252 PEEK PREVAIL CERVICAL INTERBODY DEVICE Medtronic Sofamor Danek OVE Class II 2012-01-17
K113730 PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS Parcus Medical, LLC MBI Class II 2012-01-17
K113366 LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2012-01-17
K112814 CUFFINK Cayenne Medical, Inc. MBI Class II 2012-01-17
K113329 K2M, PYRENEES CERVICAL PLATE SYSTEM K2m, Inc. KWQ Class II 2012-01-17
K112417 VARIOUS Depuy Mitek, A Johnson & Johnson Company MBI Class II 2012-01-13
K112727 MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL Medical Facets HWC Class II 2012-01-13
K113318 ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM Acute Innovations, LLC HRS Class II 2012-01-12
K113123 OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM The Orthopaedic Implant Company KTT Class II 2012-01-12
K113654 CASPIAN K2m, Inc. KWP Class II 2012-01-12
K113405 SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM Suspension Orthopaedic Solutions, LLC HRS Class II 2012-01-11
K113069 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY Biomet Manufacturing Corp PHX Class II 2012-01-11
K113138 ALEUTIAN SYSTEM K2m, Inc. MAX Class II 2012-01-10
K113625 DSS STABILIZATION SYSTEM Paradigm Spine, LLC NKB Class II 2012-01-10
K112960 LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE Cayenne Medical, Inc. MBI Class II 2012-01-09
K112169 APTUS WRIST ARTHRODESIS PLATES Medartis AG HRS Class II 2012-01-06
K113477 IVAS 20MM (10 GAUGE) BALLOON CATHETER Stryker Instruments, Instruments Div. NDN Class II 2012-01-06
K112301 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER Materialise NV HSX Class II 2012-01-06
K113242 APEX ARC HIP STEM Omni Life Science, Inc. LPH Class II 2012-01-05
K113012 PROMOS MODULAR SHOULDER SYSTEM Smith & Nephew, Inc. KWS Class II 2012-01-05
K113038 SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS Smith & Nephew, Inc. HSX Class II 2012-01-05
K113106 DNE EXTERNAL FIXATION SYSTEM Dne, LLC KTT Class II 2012-01-04
K112643 FOCUS MIS SYSTEM L&K BIOMED Co., Ltd. NKB Class II 2012-01-04
K112240 DYNA LOCKING CANNULATED SCREW U&I Corp. HWC Class II 2012-01-04
K113609 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 Exactech, Inc. LPH Class II 2012-01-04
K111068 STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 Skeletal Dynamics, LLC KYI Class II 2011-12-30
K113559 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS Ldr Spine USA, Inc. ODP Class II 2011-12-29
K112080 PRESERVE HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-12-28
K103573 ARTS2 SPINAL FIXATION SYSTEM Advanced Medical Technologies MNH Class II 2011-12-28
K112923 SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM Suspension Orthopaedic Solutions, LLC HRS Class II 2011-12-27
K112664 ZAVATION IBF SYSTEMS Zavation, LLC ODP Class II 2011-12-23
K113109 STRYKER RESORBABLE FIXATION SYSTEM Stryker HRS Class II 2011-12-23
K113591 COLS PEEK Fournitures Hospitalieres Industrie HWC Class II 2011-12-22
K112907 CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G Medos International SARL NDN Class II 2011-12-22
K112437 ARTHREX FRACTURE SYSTEM Arthrex, Inc. HTN Class II 2011-12-21
K113044 SYNTHES MIRS Synthes Spine NKB Class II 2011-12-21
K112920 RANGE SPINAL SYSTEM (MESA AND DENALI) K2m, Inc. MNI Class II 2011-12-21
K113399 IFS SUBTALAR IMPLANT Internal Fixation Systems, Inc. HWC Class II 2011-12-20
K113528 CLYDESDALE(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2011-12-20
K112941 LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS Smith & Nephew, Inc. JWH Class II 2011-12-20
K113028 MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS Medisiss HRX Class II 2011-12-20
K113523 LIMACORPORATE SMR REVERSE SHOULDER SYSTEM Lima Corporate S.P.A. PHX Class II 2011-12-20

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