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

    MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

    K Number: K083447 · Decision Feb 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    10
    Review Days
    77

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    Basic Information

    Device Name
    MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
    K Number
    K083447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Memometal Technologies
    Date Received
    November 21, 2008
    Decision Date
    February 6, 2009
    Product Code
    HRS
    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
    HRS Plate, 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
    K071941 MEMOMETAL BONE ANCHORS
    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