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

    BioSphere MIS Putty (BioSphere MIS)

    K Number: K173301 · Decision Jan 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    BioSphere MIS Putty (BioSphere MIS)
    K Number
    K173301
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synergy Biomedical, LLC
    Date Received
    October 17, 2017
    Decision Date
    January 19, 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 Synergy Biomedical, LLC

    K Number Device Name
    K122868 BIOSPHERE BIOACTIVE BONE GRAFT PUTTY