K190284 is an FDA 510(k) clearance for the Bengal Stackable Cage System. This device is classified as a Spinal Vertebral Body Replacement Device - Cervical (Class II - Special Controls, product code PLR).
Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on December 20, 2019, 312 days after receiving the submission on February 11, 2019.
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 | K190284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 312 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. |