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

    2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

    K Number: K031981 · Decision Jul 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
    K Number
    K031981
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linvatec Biomaterials, Ltd.
    Date Received
    June 26, 2003
    Decision Date
    July 25, 2003
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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    Other Clearances by Linvatec Biomaterials, Ltd.

    K Number Device Name
    K042966 DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
    K042517 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
    K042295 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
    K032447 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED