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

    SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)

    K Number: K982169 · Decision Sep 14, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    13
    Review Days
    87

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    Basic Information

    Device Name
    SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
    K Number
    K982169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Doctor'S Research Group, Inc.
    Date Received
    June 19, 1998
    Decision Date
    September 14, 1998
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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