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

    INTEGRA TITANIUM BONE WEDGE

    K Number: K131360 · Decision Aug 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    7
    Review Days
    86

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    Basic Information

    Device Name
    INTEGRA TITANIUM BONE WEDGE
    K Number
    K131360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedic
    Date Received
    May 13, 2013
    Decision Date
    August 7, 2013
    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 Ascension Orthopedic

    K Number Device Name
    K140463 INTEGRA EXTERNAL FIXATION SYSTEM
    K130050 TITAN REVERSE SHOULDER SYSTEM
    K112438 TITAN MODULAR TOTAL SHOULDER SYSTEM
    K112481 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
    K112278 ASCENSION NUGRIP CMC IMPLANT
    K111799 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM