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

    HIP SEXTANT INSTRUMENT SYSTEM

    K Number: K093491 · Decision Dec 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    394

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HIP SEXTANT INSTRUMENT SYSTEM
    K Number
    K093491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Planning Associates
    Date Received
    November 10, 2009
    Decision Date
    December 9, 2010
    Product Code
    OSF
    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
    OSF Patient Specific Manual Orthopedic Stereotaxic System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OSF), ordered by most recent decision date.

    HipXpert and HipInsight System

    FDA 510(k)
    FDA Class 2 ·Neurology

    HipXpert 3D Display and Anchoring Application

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all