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

    ENHANCED MODULAR AUSTIN MOORE HIP

    K Number: K936044 · Decision Apr 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    376
    Review Days
    127

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    Basic Information

    Device Name
    ENHANCED MODULAR AUSTIN MOORE HIP
    K Number
    K936044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3340
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zimmer, Inc.
    Date Received
    December 20, 1993
    Decision Date
    April 26, 1994
    Product Code
    KMC
    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
    KMC Prosthesis, Hip, Semi-Constrained, Composite/Metal

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