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

    ADKINS STRUT

    K Number: K091058 · Decision Jul 22, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    5
    Review Days
    100

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    Basic Information

    Device Name
    ADKINS STRUT
    K Number
    K091058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Microfixation, Inc.
    Date Received
    April 13, 2009
    Decision Date
    July 22, 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 Biomet Microfixation, Inc.

    K Number Device Name
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    K081067 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
    K071577 BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER