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

    CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS

    K Number: K003549 · Decision Feb 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    152
    Review Days
    90

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    Basic Information

    Device Name
    CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
    K Number
    K003549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    November 17, 2000
    Decision Date
    February 15, 2001
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JEY Plate, Bone

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