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

    EBI DYNAFIX VS OSTEOTOMY SYSTEM

    K Number: K010551 · Decision May 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    2
    Applicant Total
    95
    Review Days
    80

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    Basic Information

    Device Name
    EBI DYNAFIX VS OSTEOTOMY SYSTEM
    K Number
    K010551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ebi, L.P.
    Date Received
    February 26, 2001
    Decision Date
    May 17, 2001
    Product Code
    NDF
    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
    NDF Plate, Fixation, Bone, Non-Spinal, Metallic

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    K092336 C-THRU SPINAL SYSTEM
    K091381 IBEX SPINAL SYSTEM
    K090203 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
    K090523 POLARIS SPINAL SYSTEM
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