BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROXIMAL CEMENT SPACER

    Reg #: 1825034 · FEI: 1825034 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    7

    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
    K052639

    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
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    PROXIMAL CEMENT SPACER GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH

    Establishment Types

    Manufacture Medical Device