BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALICOIL 4.5 MM AWL DILATOR, REUSABLE HOLE PREPARATION FOR NORMAL AND HARD BONE QUALITY

    Reg #: 1643264 · FEI: 1643264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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

    Regulatory Submissions

    510(k) Number
    K110545

    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

    HEALICOIL 4.5 MM AWL DILATOR, REUSABLE HOLE PREPARATION FOR NORMAL AND HARD BONE QUALITY DRILL 4.5MM SPADE TIP HEALICOIL SA HEALICOIL 5.5 MM AWL DILATOR, REUSABLE HOLE PREPARATION FOR NORMAL AND HARD BONE QUALITY DRILL 3.5MM SPADE TIP HEALICOIL SA

    Establishment Types

    Manufacture Medical Device