BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Threaded Insert, Half Spacer 15mm, 20mm thickness Size #2

    Reg #: 3006791286 · FEI: 3006791286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS
    Registration Number
    3006791286
    FEI Number
    3006791286
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3063 B Philmont Ave.
    City
    Huntingdon Valley
    State
    PA
    ZIP
    19006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K024161

    Owner / Operator

    Firm Name
    Arch Medical Solutions - Philadelphia, LLC DBA JADE PRECISIO
    Operator Number
    10023130
    Address
    3063 B Philmont Ave.
    City
    Huntingdon Valley
    State
    PA
    Postal Code
    19006
    Country
    US
    Correspondent
    Christopher Bates

    Products

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

    Proprietary Names

    Threaded Insert, Half Spacer 15mm, 20mm thickness Size #2 Threaded Insert, Half Spacer 15mm, 20mm, 30mm thickness size #4 Threaded Insert, Half Spacer 15mm, 20mm, 30mm thickness Size #3 NEW-GEN RHK/LCCK Femoral Augment Screw Threaded Insert, Half Spacer 15mm, 20mm, 30mm thickness size #5 Threaded Insert, Half Spacer 15mm, 20mm, 30mm thickness size #7 Thread Insert, Half Spacer 15mm, 20mm, 30mm, thickness size #6 NEX-GEN TIBIA 115, 20, & 30mm Augment Screw

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)