K080568 is an FDA 510(k) clearance for the X-MESH EXPANDABLE CAGE SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on May 1, 2008, 62 days after receiving the submission on February 29, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K080568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2008 |
| Decision Date | May 01, 2008 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQP - Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |