BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROFILE AND MULTIDIRECTIONAL SCREWS

    Reg #: 1825034 · FEI: 1825034 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOMET, INC.
    Registration Number
    1825034
    FEI Number
    1825034
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    56 E Bell Dr, Po Box 587
    City
    WARSAW
    State
    IN
    ZIP
    46581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090877

    Owner / Operator

    Firm Name
    Biomet, Inc.
    Operator Number
    1825034
    Address
    56 East Bell Dr., PO Box 587
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Kevin W Escapule

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    PROFILE AND MULTIDIRECTIONAL SCREWS PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW

    Establishment Types

    Manufacture Medical Device