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

    SILASTIC H.P. TRAPEXIAL IMPLANT

    K Number: K781756 · Decision Nov 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    31
    Review Days
    30

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    Basic Information

    Device Name
    SILASTIC H.P. TRAPEXIAL IMPLANT
    K Number
    K781756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3770
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    October 16, 1978
    Decision Date
    November 15, 1978
    Product Code
    KYI
    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
    KYI Prosthesis, Wrist, Carpal Trapezium

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    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
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    K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
    K843995 TF-II HIP PROSTHESIS
    K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
    K840357 SSA HIP PROSTHESIS
    K831479 METAL-BACKED ACETABULAR CUP
    K812864 SILASTIC VOICE PROSTHESIS
    K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
    K811679 SILASTIC TENDON PASSER H.P.
    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →