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

    HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

    K Number: K011354 · Decision Jul 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
    K Number
    K011354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dj Orthopedics, LLC
    Date Received
    May 3, 2001
    Decision Date
    July 31, 2001
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Dj Orthopedics, LLC

    K Number Device Name
    K021740 TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
    K010594 DJ ORTHOPEDICS POST SCREW
    K010595 DJ ORTHOPEDICS INTERFERENCE SCREW
    K002829 DJ ORTHOPEDICS FEMORAL ANCHOR
    K003960 DJ ORTHOPEDICS TIBIAL ANCHOR