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

    BONEOPTIMIZER

    K Number: K100841 · Decision Aug 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    10
    Review Days
    147

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    Basic Information

    Device Name
    BONEOPTIMIZER
    K Number
    K100841
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curasan AG
    Date Received
    March 25, 2010
    Decision Date
    August 19, 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 Curasan AG

    K Number Device Name
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    K160566 Cerasorb Ortho Foam
    K111105 CURASAN OSSEOLIVE DENTAL
    K103709 CERACELL DENTAL
    K102872 OSBONE DENTAL
    K063106 REVOIS IMPLANT SYSTEM
    K040216 CERASORB M ORTHO
    K031651 MODIFICATION TO CERASORB ORTHO
    K014156 CERASORB ORTHO