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

    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

    K Number: K013072 · Decision Nov 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    11
    Review Days
    439

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    Basic Information

    Device Name
    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
    K Number
    K013072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes
    Date Received
    September 13, 2001
    Decision Date
    November 26, 2002
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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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
    K020602 SYNTHES PILON PLATE
    K010108 USS-LINE EXTENSION
    K003836 SYNTHES SYNEX SPACER SYSTEM
    K003061 SYNTHES USS (10.0MM SIDE OPENING SCREWS)
    K982732 SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
    Search all 11 clearances from Synthes →