K243375 is an FDA 510(k) clearance 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 Cleared decision on November 29, 2024, 30 days after receiving the submission on October 30, 2024.
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 | K243375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2024 |
| Decision Date | November 29, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| 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. |