BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    MaxiGen

    K Number: K152077 · Decision Apr 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    269

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    Basic Information

    Device Name
    MaxiGen
    K Number
    K152077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hans Biomed Corp.
    Date Received
    July 27, 2015
    Decision Date
    April 21, 2016
    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 Hans Biomed Corp.

    K Number Device Name
    K151271 BellaFuse
    K130235 SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
    K113728 SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY