BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TWINFIX 3.5 Suture Anchor with ULTRABRAID Sutures with Needles

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1219602
    FEI Number
    1219602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    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

    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