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

    Osteocera Resorbable Bone Substitute

    K Number: K180758 · Decision Oct 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    5
    Review Days
    216

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    Basic Information

    Device Name
    Osteocera Resorbable Bone Substitute
    K Number
    K180758
    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
    March 22, 2018
    Decision Date
    October 24, 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 Wiltrom Corporation Limited

    K Number Device Name
    K202894 Wiltrom Spinal Fixation System
    K172237 Bicera Resorbable Bone Substitute
    K172548 Wiltrom Spinal Fixation System
    K110949 BICERA (TM) RESORBABLE BONE SUBSTITUTE