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

    4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM

    K Number: K110354 · Decision Mar 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    25

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
    K Number
    K110354
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA
    Date Received
    February 7, 2011
    Decision Date
    March 4, 2011
    Product Code
    JDP
    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
    JDP Condylar Plate Fixation Implant

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JDP), ordered by most recent decision date.

    Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    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)
    K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
    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