BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000

    K Number: K051362 · Decision Aug 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    14
    Review Days
    71

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    Basic Information

    Device Name
    INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
    K Number
    K051362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inion OY
    Date Received
    May 25, 2005
    Decision Date
    August 4, 2005
    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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