BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Klassic HD® Femoral Stem, Nonporous

    Reg #: 3008544874 · FEI: 3008544874 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TOTAL JOINT ORTHOPEDICS, INC.
    Registration Number
    3008544874
    FEI Number
    3008544874
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1567 E. Stratford Avenue
    City
    Salt Lake City
    State
    UT
    ZIP
    84106
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100445

    Owner / Operator

    Firm Name
    Total Joint Orthopedics, Inc
    Operator Number
    10036774
    Address
    1567 E. Stratford Avenue
    City
    Salt Lake City
    State
    UT
    Postal Code
    84106
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ

    Proprietary Names

    Klassic HD® Femoral Stem, Nonporous Klassic HD® Femoral Head Klassic HD® Acetabular Cup w/Ti-Coat Klassic HD® Acetabular Insert Klassic HD® Femoral Head Adapter Sleeve Klassic HD® Acetabular Insert XLPE Klassic HD® Femoral Stem, Porous Klassic HD® Cancellous Bone Screw

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198