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

    CarriGen PF

    K Number: K182107 · Decision Aug 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    CarriGen PF
    K Number
    K182107
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etex Corporation
    Date Received
    August 3, 2018
    Decision Date
    August 31, 2018
    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 Etex Corporation

    K Number Device Name
    K243609 EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
    K132868 CARRICELL
    K141245 ETEX MIXING AND DELIVERY SYSTEM
    K102812 GAMMA-BSM; BETA-BSM; EQUIVABONE