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

    OGDEN ANCHOR (MODIFICATION)

    K Number: K935167 · Decision Jul 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    14
    Review Days
    258

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    Basic Information

    Device Name
    OGDEN ANCHOR (MODIFICATION)
    K Number
    K935167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    American Medical Electronics, Inc.
    Date Received
    October 27, 1993
    Decision Date
    July 12, 1994
    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 American Medical Electronics, Inc.

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    K951545 OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
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    K931381 AME UNIVERSAL FIXATION SYSTEM
    K935065 OGDEN ANCHOR ADDITIONAL APPLICATIONS
    K942300 SILKON TITANIUM CABLE SYSTEM
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