BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    BICERA (TM) RESORBABLE BONE SUBSTITUTE

    K Number: K110949 · Decision Sep 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    5
    Review Days
    533

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    Basic Information

    Device Name
    BICERA (TM) RESORBABLE BONE SUBSTITUTE
    K Number
    K110949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wiltrom Corporation Limited
    Date Received
    April 4, 2011
    Decision Date
    September 18, 2012
    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 Wiltrom Corporation Limited

    K Number Device Name
    K202894 Wiltrom Spinal Fixation System
    K180758 Osteocera Resorbable Bone Substitute
    K172237 Bicera Resorbable Bone Substitute
    K172548 Wiltrom Spinal Fixation System