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

    AME(R) UNIVERSIAL CABLE SYSTEM

    K Number: K932687 · Decision May 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    14
    Review Days
    334

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    Basic Information

    Device Name
    AME(R) UNIVERSIAL CABLE SYSTEM
    K Number
    K932687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Electronics, Inc.
    Date Received
    June 3, 1993
    Decision Date
    May 3, 1994
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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    Other Clearances by American Medical Electronics, Inc.

    K Number Device Name
    K951232 EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
    K952348 OGDEN ANCHOR
    K950875 OGDEN ANCHOR
    K951493 OGDEN ANCHOR
    K951545 OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
    K941029 OGDEN ANCHOR-SMALL (TENTATIVE)
    K931381 AME UNIVERSAL FIXATION SYSTEM
    K935065 OGDEN ANCHOR ADDITIONAL APPLICATIONS
    K942300 SILKON TITANIUM CABLE SYSTEM
    K935167 OGDEN ANCHOR (MODIFICATION)
    Search all 14 clearances from American Medical Electronics, Inc. →