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

    POROCOAT SCHATZKER II ACETABULUM

    K Number: K852193 · Decision Jul 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    303
    Review Days
    71

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    Basic Information

    Device Name
    POROCOAT SCHATZKER II ACETABULUM
    K Number
    K852193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Depuy, Inc.
    Date Received
    May 20, 1985
    Decision Date
    July 30, 1985
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Depuy, Inc.

    K Number Device Name
    K043058 PINNACLE CONSTRAINED ACETABULAR LINERS
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    K033959 LPS
    K040544 DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
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    K032151 DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
    K020541 AGILITY ANKLE REVISION PROSTHESIS
    K011810 ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
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