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

    PLLA, HA SCREW

    K Number: K080358 · Decision Apr 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    10
    Review Days
    72

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    Basic Information

    Device Name
    PLLA, HA SCREW
    K Number
    K080358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Inc., Endoscopy Div.
    Date Received
    February 11, 2008
    Decision Date
    April 23, 2008
    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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