BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUTURE TENSIONER

    Reg #: 1643264 · FEI: 1643264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1643264
    FEI Number
    1643264
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ENDOSCOPY, 76 S. MERIDIAN AVE.
    City
    OKLAHOMA CITY
    State
    OK
    ZIP
    73107
    Country
    US

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Guide, Surgical, Instrument FZX

    Proprietary Names

    SUTURE TENSIONER ARO Osteotomy Guide Assembly ARO Spacer Plate TRIGEN GENESIS II LEGION JET-X AMBI PERI-LOC Guide SURFIX Forefoot II K-WIRE TIBIAXYS Integra LARGE QWIX SURFIX ALPHA HALLU-LOCK ENGAGE PANTA HALLU-FIX SURFIX OSTEOTOME I.CO.S. DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM SPACER PLATE ARO 6MM DRIVER PIP PROXIMAL PHALANX 10 DEGREE TAP PIP PROXIMAL PHALANX 2.7MM ELEVATOR COTTLE GUIDE METATARSAL OSTEOTOMY TAP PIP PROXIMA PHALANX 3.2MM SNAP CLAMP SPACER PLATE ARO 4MM HANDLE MODULAR SPACER PLATE ARO 2MM DART SUTURE PASSER RASP DOUBLE ENDED Guide-TRAC DRILL GUIDE PHALANGEAL EXTRA ARTICULAR DRIVER CANNULATED SCREW TAP CANNULATED SCREW SPACER PLATE ARO 5MM DRIVER PIP PROXIMAL PHALANX TAP PIP MIDDLE PHALANX 4MM TAP PIP PROXIMA PHALANX 3.7MM TAP PIP MIDDLE PHALANX 5MM DRIVER PIP MIDDLE PHALANX TAP PIP PROXIMA PHALANX 4.2MM SPACER PLATE ARO 3MM DRILL GUIDE PHALANGEAL SHORT OFFSET WILSON RETRACTOR TRIGGER DRILL GUIDE PHALANGEAL LONG OFFSET

    Establishment Types

    Manufacture Medical Device