BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Klassic HD Hooded Acetabular Insert with XLPE

    Reg #: 3008544874 · FEI: 3008544874 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    5

    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
    K180929

    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, Metal/Polymer, Porous Uncemented LPH
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ

    Proprietary Names

    Klassic HD Hooded Acetabular Insert with XLPE Klassic HD Hooded Acetabular Insert with E-Link Poly, 28mm head Klassic HD Low Profile Acetabular Insert with E-Link Poly, 22mm head 22mm BIOLOX delta Ceramic Femoral Head Klassic HD Acetabular Cup with Ti-Coat, 44mm Klassic HD Low Profile Acetabular Insert with XLPE Klassic HD Low Profile Acetabular Insert with E-Link Poly, 28mm head Klassic HD Acetabular Insert with XLPE, 28mm head Klassic HD Acetabular Insert with E-Link Poly, 22mm head Klassic HD Hooded Acetabular Insert with E-Link Poly, 22mm head Klassic HD Acetabular Insert with E-Link Poly, 28mm head Klassic HD Acetabular Cup with Ti-Coat, 46mm Klassic HD Acetabular Insert with XLPE, 22mm head 28mm BIOLOX delta Ceramic Femoral Head 28mm BIOLOX OPTION Femoral Head, 16/18 taper

    Establishment Types

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