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

    OSTEOPHIL BETA-TCP

    K Number: K102937 · Decision Dec 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    8
    Review Days
    84

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    Basic Information

    Device Name
    OSTEOPHIL BETA-TCP
    K Number
    K102937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytophil, Inc.
    Date Received
    October 4, 2010
    Decision Date
    December 27, 2010
    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 Cytophil, Inc.

    K Number Device Name
    K150400 Renu Gel
    K121795 CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
    K093871 PERIOPHIL B-TCP
    K092788 PERIOPHIL BIPHASIC
    K081815 VOCALIS GEL
    K081816 VOCALIS AND VOCALIS SM
    K072219 CYTOPHIL TISSUE MARKER