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

    SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)

    K Number: K812053 · Decision Aug 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    15
    Applicant Total
    31
    Review Days
    28

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    Basic Information

    Device Name
    SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
    K Number
    K812053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3810
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    July 21, 1981
    Decision Date
    August 18, 1981
    Product Code
    KXE
    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
    KXE Prosthesis, Wrist, Hemi-, Ulnar

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