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

    Synergy Disc Instruments

    K Number: K253392 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    178

    Basic Information

    Device Name
    Synergy Disc Instruments
    K Number
    K253392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4515
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synergy Spine Solutions, Inc.
    Date Received
    September 30, 2025
    Decision Date
    March 27, 2026
    Product Code
    QLQ
    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
    QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices

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