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

    METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET

    K Number: K113752 · Decision Feb 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    8
    Review Days
    47

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    Basic Information

    Device Name
    METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
    K Number
    K113752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solana Surgical, LLC
    Date Received
    December 21, 2011
    Decision Date
    February 6, 2012
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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    Other Clearances by Solana Surgical, LLC

    K Number Device Name
    K132594 CROSSCHECK PLATING SYSTEM
    K131187 LESSER METATARSAL HEAD IMPLANT SYSTEM
    K124045 FUSEFORCE IMPLANT SYSTEM
    K122738 GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
    K120390 SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
    K120029 HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
    K090127 METATARSAL DECOMPRESSION IMPLANT, MODEL 100