K110864 is an FDA 510(k) clearance for the BIOSPINE VBR SYSTEM. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on June 15, 2011, 78 days after receiving the submission on March 29, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K110864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2011 |
| Decision Date | June 15, 2011 |
| Days to Decision | 78 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 |