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

    TITANIUM MESH

    K Number: K903485 · Decision Feb 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    205

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    Basic Information

    Device Name
    TITANIUM MESH
    K Number
    K903485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Ruggles Corp.
    Date Received
    July 31, 1990
    Decision Date
    February 21, 1991
    Product Code
    GWO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWO Plate, Cranioplasty, Preformed, Alterable

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    Other Clearances by Ruggles Corp.

    K Number Device Name
    K902818 MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT
    K902819 LAMINECTOMY ROGEUR
    K902850 ZEPPELIN INSTRUMENTS
    K893415 TRANS-ORAL DEPTH GAUGE