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

    SPECTRUM DESIGNS PROJECTION MALAR IMPLANT

    K Number: K980141 · Decision Mar 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    18
    Review Days
    47

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    Basic Information

    Device Name
    SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
    K Number
    K980141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Designs, Inc.
    Date Received
    January 15, 1998
    Decision Date
    March 3, 1998
    Product Code
    LZK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZK Implant, Malar

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    Other Clearances by Spectrum Designs, Inc.

    K Number Device Name
    K992522 SPECTRUM DESIGNS SPECTRAGEL
    K982688 SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
    K980462 SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
    K980446 SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
    K980444 SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
    K980463 SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
    K980445 SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
    K980138 SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
    K980461 SPECTRUM DESIGNS CLEFT CHIN IMPLANT
    K980140 SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
    Search all 18 clearances from Spectrum Designs, Inc. →