BEUDAMED
    Product Code: QWL FDA class 2 21 CFR 888.4560

    Intraoperative Surgical Angle Measurement Tool

    Orthopedic

    The intraoperative surgical angle measurement tool (product code QWL) is a Class 2 Orthopedic device (regulation 888.4560) that attaches to surgical instruments to measure their angle relative to a vertical plumb line aligned with gravity during surgical procedures. It requires 510(k) clearance and does not utilize anatomic landmarks or registration to patient anatomy. Although flagged as an implant in the record, it functions as an instrument attachment rather than a permanently implanted component; it is not life-sustaining.

    View on FDA
    510(k)s
    3
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    2

    Research product code QWL in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QWL
    Device Class
    FDA class 2
    Regulation Number
    888.4560
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K252615 Ruthless Spine RJB
    K243375 Ruthless Spine RJB
    DEN230012 Ruthless Spine RJB

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.