K193412 is an FDA 510(k) clearance for the NEXXT MATRIXX System. This device is classified as a Spinal Vertebral Body Replacement Device - Cervical (Class II - Special Controls, product code PLR).
Submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on February 24, 2020, 77 days after receiving the submission on December 9, 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 | K193412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2019 |
| Decision Date | February 24, 2020 |
| Days to Decision | 77 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. |