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

    DJ ORTHOPEDICS INTERFERENCE SCREW

    K Number: K010595 · Decision May 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    6
    Review Days
    69

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    Basic Information

    Device Name
    DJ ORTHOPEDICS INTERFERENCE SCREW
    K Number
    K010595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dj Orthopedics, LLC
    Date Received
    February 28, 2001
    Decision Date
    May 8, 2001
    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 Dj Orthopedics, LLC

    K Number Device Name
    K021740 TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
    K011354 HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
    K010594 DJ ORTHOPEDICS POST SCREW
    K002829 DJ ORTHOPEDICS FEMORAL ANCHOR
    K003960 DJ ORTHOPEDICS TIBIAL ANCHOR