BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SN 6314 A-A GAGE

    Reg #: 3010386387 · FEI: 3010386387 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SINGLE SOURCE MEDICAL LLC
    Registration Number
    3010386387
    FEI Number
    3010386387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4506 S State Road 9 57
    City
    Churubusco
    State
    IN
    ZIP
    46723
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103404

    Owner / Operator

    Firm Name
    Single Source Medical LLC
    Operator Number
    10043888
    Address
    4506 IN 9-57
    City
    Churubusco
    State
    IN
    Postal Code
    46723
    Country
    US
    Correspondent
    Tom Harris

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    SN 6314 A-A GAGE SSI006704 Retro Nail Connect Bolt + 5cm SSI006692 ZNN Retro Targeting Guide Extended SSI006705 Retro Nail Depth Gauge +5 cm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)