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

    Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

    K Number: K252597 · Decision Feb 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    93
    Review Days
    188

    Basic Information

    Device Name
    Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
    K Number
    K252597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alphatec Spine, Inc.
    Date Received
    August 15, 2025
    Decision Date
    February 19, 2026
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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