BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    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
    K102660

    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 SA PK 5.5MM W/3 UB-BL CBBL LT DRILL GUIDE CRVD FOR 2.3 SA CROWN CURVED DRILL GUIDE FOR 2.3 MM SUTURE ANCHORS, FISHMOUTH TIP TWIST DRILL FLEX CRVD FOR 2.3 SA

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device