BEUDAMED
    FDA Registration Active 🇺🇸 United States

    31-479568 BIPOLAR/ENDO PROV CUP 28X58MM

    Reg #: 3010386387 · FEI: 3010386387 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    5

    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
    K051569

    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, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY

    Proprietary Names

    31-479568 BIPOLAR/ENDO PROV CUP 28X58MM 31-479560 BIPOLAR/ENDO PROV CUP 28X50MM 31-479557 BIPOLAR/ENDO PROV CUP 28X47MM 31-479558 BIPOLAR/ENDO PROV CUP 28X48MM 31-479562 BIPOLAR/ENDO PROV CUP 28X52MM 31-479553 BIPOLAR/ENDO PROV CUP 28X43MM 31-479564 BIPOLAR/ENDO PROV CUP 28X54MM 31-479561 BIPOLAR/ENDO PROV CUP 28X51MM 31-479565 BIPOLAR/ENDO PROV CUP 28X55MM 31-479555 BIPOLAR/ENDO PROV CUP 28X45MM 31-479552 BIPOLAR/ENDO PROV CUP 28X42MM 31-479551 BIPOLAR/ENDO PROV CUP 28X41MM 31-479554 BIPOLAR/ENDO PROV CUP 28X44MM 31-479556 BIPOLAR/ENDO PROV CUP 28X46MM 31-479559 BIPOLAR/ENDO PROV CUP 28X49MM 31-479563 BIPOLAR/ENDO PROV CUP 28X53MM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)