K102315 is an FDA 510(k) clearance for the STAXX XDL SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on August 19, 2011, 368 days after receiving the submission on August 16, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K102315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2010 |
| Decision Date | August 19, 2011 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| 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 |