QWL — Intraoperative Surgical Angle Measurement Tool Class II
FDA product code QWL covers "Intraoperative Surgical Angle Measurement Tool", a Class II medical device regulated under 21 CFR 888.4560. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QWL
- Device Class
- Class II
- Regulation Number
- 888.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.