BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StageOne Knee Tibial Cement Spacer Mold, M/L 70mm, A/P 42mm

    Reg #: 2025182 · FEI: 2025182 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Freudenberg Medical, LLC
    Registration Number
    2025182
    FEI Number
    2025182
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1110 Mark Ave
    City
    CARPINTERIA
    State
    CA
    ZIP
    93013
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213287

    Owner / Operator

    Firm Name
    Freudenberg Medical, LLC
    Operator Number
    2025182
    Address
    Freudenberg Medical, LLC, 1110 Mark Avenue
    City
    Carpinteria
    State
    CA
    Postal Code
    93013
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Bone Cement, Antibiotic MBB

    Proprietary Names

    StageOne Knee Tibial Cement Spacer Mold, M/L 70mm, A/P 42mm StageOne Knee Femoral Cement Spacer Mold, M/L 65mm, A/P 48mm StageOne Knee Femoral Cement Spacer Mold, M/L 75mm, A/P 57mm StageOne Knee Tibial Cement Spacer Mold, M/L 75mm, A/P 45mm StageOne Knee Femoral Cement Spacer Mold, M/L 70mm, A/P 52mm StageOne Knee Femoral Cement Spacer Mold, M/L 60mm, A/P 43mm StageOne Knee Tibial Cement Spacer Mold, M/L 80mm, A/P 48mm StageOne Knee Cement Spacer Mold StageOne Knee Tibial Cement Spacer Mold, M/L 65mm, A/P 39mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)