BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUTUREFIX ULTRA DRILL1.7MM XL DISPOSAB

    Reg #: 3003604053 · FEI: 3003604053 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    3003604053
    FEI Number
    3003604053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 150 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122059

    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

    SUTUREFIX ULTRA DRILL1.7MM XL DISPOSAB ELITE KNOT PUSHER XL OBTURATOR S BLUNT REUSABLE TWIST DRILL FOR 1.7MM ALL STR ANCHRS SUTUREFIX Ultra Suture Anchor All- Suture 1.9mm Anchor with ULTRABRAID Suture All-Suture 1.7mm Anchor with ULTRABRAID Suture SUTUREFIX Ultra, 1.9mm Drill, S 72203856 Drill, 1.7mm S, Disposable 72203855 SUTUREFIX ULTRA AHR S 2 UB STR BLUE SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH DRILL GUIDE CROWN TIP REUSABLE STANDARD DRILL GUIDE S FISHMOUTH REUSABLE DRILL GUIDE CROWN TIP REUSABLE XL SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL SUTUREFIX ULTRA AHR S 2 UB STR CB BLU OBTURATOR XL CANNULATED BLUNT TIP TWIST DRILL FOR 1.9MM ALL STR ANCHRS OBTURATOR XL BLUNT TIP OBTURATOR S TROCAR TIP REUSABLE DRILL GUIDE XL SPIKE TIP SUTUREFIX UL ANR XL W/1 2 ULTRABRIAD BL OBTURATOR S CANNULATED REUSABLE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility