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

    MODIFICATION TO LAPIDUS PLATE

    K Number: K070241 · Decision Feb 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    28
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO LAPIDUS PLATE
    K Number
    K070241
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Deal, S.A.
    Date Received
    January 25, 2007
    Decision Date
    February 8, 2007
    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 New Deal, S.A.

    K Number Device Name
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    K063820 LISFRANC PLATE
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    K061765 KALIX II IMPLANT
    K061594 LARGE UNI-CLIP STAPLE
    K060476 LAPIDUS PLATE
    K060473 TTC PLATE
    K053093 KALIX II IMPLANT, MODEL 141 0XX WITH XX
    K052152 B-BOP PLATE
    K050882 NEWDEAL ANKLE NAIL
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