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

    PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS

    K Number: K101126 · Decision Dec 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
    K Number
    K101126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Core Essence Orthopaedics, Inc.
    Date Received
    April 22, 2010
    Decision Date
    December 2, 2010
    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 Core Essence Orthopaedics, Inc.

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