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

    COMPRESSYN STAPLE

    K Number: K140358 · Decision Jun 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    10
    Review Days
    110

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    Basic Information

    Device Name
    COMPRESSYN STAPLE
    K Number
    K140358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dallen Medical, Inc.
    Date Received
    February 12, 2014
    Decision Date
    June 2, 2014
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Dallen Medical, Inc.

    K Number Device Name
    K171473 Compressyn™ Staple
    K150359 Tensyn Plug
    K143092 Tensyn Plug
    K141264 TENSYN BAND, TENSYN FRACTURE PLATES
    K133858 TENSYN BAND
    K132875 COMPRESSYN STAPLE
    K131850 TENSYN BAND
    K130431 COMPRESSYN BAND
    K122871 COMPRESSYN STAPLE