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

    META-LOCK SUTURE ANCHOR SYSTEM

    K Number: K110800 · Decision Sep 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    2
    Review Days
    189

    Basic Information

    Device Name
    META-LOCK SUTURE ANCHOR SYSTEM
    K Number
    K110800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TARSUS MEDICAL INC.
    Date Received
    March 22, 2011
    Decision Date
    September 27, 2011
    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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    Other Clearances by TARSUS MEDICAL INC.

    K Number Device Name
    K111971 SYNDE-LOCK SYNDESMOSIS REPAIR KIT