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

    P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM

    K Number: K954481 · Decision Oct 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    206
    Review Days
    379

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    Basic Information

    Device Name
    P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
    K Number
    K954481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    September 27, 1995
    Decision Date
    October 10, 1996
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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