K151651 is an FDA 510(k) clearance for the NuVasive X-CORE Mini Cervical Expandable VBR System. This device is classified as a Spinal Vertebral Body Replacement Device - Cervical (Class II - Special Controls, product code PLR).
Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on September 25, 2015, 99 days after receiving the submission on June 18, 2015.
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 | K151651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2015 |
| Decision Date | September 25, 2015 |
| Days to Decision | 99 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. |