K232481 is an FDA 510(k) clearance for the RIGEL™ 3DR Anterior Cervical Corpectomy System. This device is classified as a Spinal Vertebral Body Replacement Device - Cervical (Class II - Special Controls, product code PLR).
Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on October 13, 2023, 58 days after receiving the submission on August 16, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060. Vertebral Body Replacement In The Cervical Spine..
| 510(k) Number | K232481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2023 |
| Decision Date | October 13, 2023 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLR — Spinal Vertebral Body Replacement Device - Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
| Definition | Vertebral Body Replacement In The Cervical Spine. |