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

    CONNEXX LOCKING TIBIA NAIL

    K Number: K080706 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    89

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    Basic Information

    Device Name
    CONNEXX LOCKING TIBIA NAIL
    K Number
    K080706
    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
    March 12, 2008
    Decision Date
    June 9, 2008
    Product Code
    JDS
    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
    JDS Nail, Fixation, Bone

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    Other Clearances by I.T.S. Implantat-Technologie-Systeme GmbH

    K Number Device Name
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    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 →