BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇺🇸 United States

    F-20 CEMENTED METAL-BACKED ACETABULAR CUP

    K Number: K901451 · Decision Aug 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    16
    Review Days
    151

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    Basic Information

    Device Name
    F-20 CEMENTED METAL-BACKED ACETABULAR CUP
    K Number
    K901451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Med-Tek Corp.
    Date Received
    April 2, 1990
    Decision Date
    August 31, 1990
    Product Code
    JDI
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Med-Tek Corp.

    K Number Device Name
    K903234 F-19 TOTAL HIP PROSTHESIS
    K901687 F-24 FEMORAL HIP PROSTHESIS
    K900428 ANESTHESIA BREATHING CIRCUITS
    K901626 H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
    K901594 H.N. TOTAL HIP PROSTHESIS
    K901480 F-20 TOTAL HIP PROSTHESIS
    K901273 L.M.S. SELF-DETACHABLE BROACH WITH STOP
    K901272 ORION BLADE PLATE FOR TIBIAL OSTEOTOMY
    K901240 ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
    K894978 BACTERIAL FILTER
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