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

    SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

    K Number: K120070 · Decision Mar 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    9
    Review Days
    72

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    Basic Information

    Device Name
    SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
    K Number
    K120070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA
    Date Received
    January 9, 2012
    Decision Date
    March 21, 2012
    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 Synthes USA

    K Number Device Name
    K141527 DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
    K121601 SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
    K120854 SYNTHES VA LCP ANKLE TRAUMA SYSTEM
    K120717 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
    K120083 SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
    K110592 3.7MM/5.0MM DYNAMIC LOCKING SCREW
    K110125 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
    K110354 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM