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

    FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER

    K Number: K852026 · Decision May 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    24
    Review Days
    14

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    Basic Information

    Device Name
    FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
    K Number
    K852026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Warsaw Orthopedic, Inc.
    Date Received
    May 8, 1985
    Decision Date
    May 22, 1985
    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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    K880211 TSRH H/M HOOK HOLDER
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    K880214 TSRH H/M TORQUE LIMITING WRENCH
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