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

    REFIX INTERNAL FRACTURE FIXATION SCREWS

    K Number: K050388 · Decision Sep 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    REFIX INTERNAL FRACTURE FIXATION SCREWS
    K Number
    K050388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xtremi-T, LLC
    Date Received
    February 15, 2005
    Decision Date
    September 7, 2005
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Xtremi-T, LLC

    K Number Device Name
    K043339 REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG