BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Integra Titanium Bone Wedge

    Reg #: 3014207283 · FEI: 3002788818 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ascension Orthopedics, Inc.
    Registration Number
    3014207283
    FEI Number
    3002788818
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11101 Metric Blvd
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131360

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    Integra Titanium Bone Wedge

    Establishment Types

    Manufacture Medical Device