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

    DISTAL HUMERAL PLATES WITH ANGULAR STABILITY

    K Number: K080184 · Decision Mar 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    13
    Review Days
    61

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    Basic Information

    Device Name
    DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
    K Number
    K080184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.T.S. Implantat-Technologie-Systeme GmbH
    Date Received
    January 25, 2008
    Decision Date
    March 26, 2008
    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 I.T.S. Implantat-Technologie-Systeme GmbH

    K Number Device Name
    K093868 I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
    K080706 CONNEXX LOCKING TIBIA NAIL
    K063672 FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
    K063166 I.T.S. PELVIC RECONSTRUCTION SYSTEM
    K060156 STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
    K052368 OLECRANONPLATE WITH ANGULAR STABILITY
    K051642 FR.O.H. CALCANEUS REPAIR SYSTEM
    K052011 PILONPLATE WITH ANGULAR STABILITY
    K051412 HUMERAL HEAD PLATE WITH ANGULAR STABILITY
    K050852 CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
    Search all 13 clearances from I.T.S. Implantat-Technologie-Systeme GmbH →