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

    SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

    K Number: K171568 · Decision Feb 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    4
    Review Days
    268

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    Basic Information

    Device Name
    SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
    K Number
    K171568
    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 Corporation
    Date Received
    May 30, 2017
    Decision Date
    February 22, 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 Hans Biomed Corporation

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    K192423 MINT Product Family
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