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

    OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS

    K Number: K103309 · Decision Feb 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    18
    Review Days
    85

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    Basic Information

    Device Name
    OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
    K Number
    K103309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Endoscopy, Inc.
    Date Received
    November 10, 2010
    Decision Date
    February 3, 2011
    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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