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510(k) Data Aggregation

    K Number
    K050357
    Device Name
    CAMCERAM TCP
    Manufacturer
    CAM IMPLANTS B.V.
    Date Cleared
    2005-04-21

    (66 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAM IMPLANTS B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
    Device Description
    CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.
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