BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CASF CANCELLOUS BONE SCREW, BT650

    K Number: K882934 · Decision Oct 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    9
    Review Days
    92

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    Basic Information

    Device Name
    CASF CANCELLOUS BONE SCREW, BT650
    K Number
    K882934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Terray Manufacturing, Inc.
    Date Received
    July 13, 1988
    Decision Date
    October 13, 1988
    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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