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

    ACTIVELOCK MODULAR FEMORAL HIP SYSTEM

    K Number: K980020 · Decision Apr 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
    K Number
    K980020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Metagen, LLC
    Date Received
    January 5, 1998
    Decision Date
    April 3, 1998
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Metagen, LLC

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    K980609 SEGMENTAL DEFECT REPLACEMENT SYSTEM
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    K963700 METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM