BEUDAMED
    Product Code: OSE FDA class 2 21 CFR 882.4560

    Patient Specific Manual Navigation System

    Neurology

    The Patient Specific Manual Navigation System (product code OSE) is a surgical planning and guidance device intended for defining implant alignment relative to a patient's individual anatomy. It is a manual, patient-specific system used during orthopedic procedures to improve placement accuracy. As an FDA Class 2 device under regulation 882.4560, it requires 510(k) premarket clearance, falls within the Neurology specialty by classification, and is reviewed by the Orthopedic panel. The device is not an implant itself and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    OSE
    Device Class
    FDA class 2
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Intended for defining implant alignment relative to a patient's anatomy.