DEN230012 is an FDA 510(k) submission for the Ruthless Spine RJB. This device is classified as a Intraoperative Surgical Angle Measurement Tool (Class II - Special Controls, product code QWL).
Submitted by Ruthless, LLC Dba Ruthless Spine (Irwindale, US). The FDA issued a Not Cleared (DENG) decision on July 14, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4560. 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) Number | DEN230012 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 16, 2023 |
| Decision Date | July 14, 2023 |
| Days to Decision | 148 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QWL - Intraoperative Surgical Angle Measurement Tool |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4560 |
| 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. |