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

    PROVIDENT HP SYSTEM

    K Number: K946371 · Decision Apr 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    40
    Review Days
    120

    Basic Information

    Device Name
    PROVIDENT HP SYSTEM
    K Number
    K946371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    STELKAST COMPANY
    Date Received
    December 6, 1994
    Decision Date
    April 5, 1995
    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 STELKAST COMPANY

    K Number Device Name
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    K094035 EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
    K081458 PROVEN STEM EXTENDER
    K063211 PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
    K051976 PROVEN REVISION MODULAR TIBIAL TRAY
    K033944 STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
    K032824 STELKAST UNICONDYLAR KNEE SYSTEM
    K031901 PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
    K032110 PROCLASS PRESS FIT HIP STEM
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