BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    MEMOMETAL BONE ANCHORS

    K Number: K071941 · Decision Dec 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    10
    Review Days
    144

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    Basic Information

    Device Name
    MEMOMETAL BONE ANCHORS
    K Number
    K071941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Memometal Technologies
    Date Received
    July 13, 2007
    Decision Date
    December 4, 2007
    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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    Other Clearances by Memometal Technologies

    K Number Device Name
    K112197 MEMOMETAL INTRA-MEDULLARY BONE FASTENER
    K101930 MEMOMETAL NAVIS BONE PLATING SYSTEM
    K102072 MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
    K093820 SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
    K083447 MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
    K070598 MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
    K070039 MEMOMETAL FIXOS SCREWS
    K070031 MEMOMETAL MEMORY STAPLES
    K070033 MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10