510(k) DEN230012
DEN230012 is an FDA 510(k) premarket notification submitted by Ruthless, LLC Dba Ruthless Spine for the device "Ruthless Spine RJB". The FDA issued a decision of De Novo Granted on July 14, 2023. The device falls under product code QWL (Intraoperative Surgical Angle Measurement Tool), a Class II device regulated under 21 CFR 888.4560. Ruthless, LLC Dba Ruthless Spine has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 14, 2023
- Date Received
- February 16, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoperative Surgical Angle Measurement Tool
- Device Class
- Class II
- Regulation Number
- 888.4560
- Review Panel
- OR
- Submission Type
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.