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

    AAP BONE SCREW

    K Number: K915316 · Decision Feb 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    AAP BONE SCREW
    K Number
    K915316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aap International, Ltd.
    Date Received
    November 22, 1991
    Decision Date
    February 14, 1992
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Aap International, Ltd.

    K Number Device Name
    K915315 AAP BONE PLATE