BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    TWINFIX 3.5 Suture Anchor with ULTRABRAID Sutures with Needles

    Reg #: 3012358417 · FEI: 3012358417 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Arthrocare Corporation
    Registration Number
    3012358417
    FEI Number
    3012358417
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B32.1, St2, Zona Franca Coyol
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K123425

    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

    US Agent

    Business Name
    Smith & Nephew, Inc.
    Contact Name
    Lisa Ewing
    Address
    2875 Railroad St
    City
    Pittsburgh
    State
    PA
    ZIP
    15222
    Country
    US
    Email
    [email protected]
    Phone
    412 4199765

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    TWINFIX 3.5 Suture Anchor with ULTRABRAID Sutures with Needles DRILL, 2.5 MM FOR 3.5 MM TWINFIX SUTURE ANCHOR, SL DRILL GUIDE SLOTTED SPIKE TIP SL TWINFIX TITANIUM 3.5 MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURES No.2 AND NEEDLES, SL

    Establishment Types

    Manufacture Medical Device