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

    SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)

    K Number: K982732 · Decision Oct 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    11
    Review Days
    64

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    Basic Information

    Device Name
    SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
    K Number
    K982732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes
    Date Received
    August 5, 1998
    Decision Date
    October 8, 1998
    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

    K Number Device Name
    K123723 SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
    K122455 SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
    K113071 SYNTHECEL DURA REPLACEMENT DEVICES
    K110604 VBB SYSTEM
    K093772 SYNTHES STERNAL FIXATION SYSTEM
    K013072 CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
    K020602 SYNTHES PILON PLATE
    K010108 USS-LINE EXTENSION
    K003836 SYNTHES SYNEX SPACER SYSTEM
    K003061 SYNTHES USS (10.0MM SIDE OPENING SCREWS)
    Search all 11 clearances from Synthes →