K183197 is an FDA 510(k) clearance for the PYRAMESH™ Implant System. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 4, 2019, 136 days after receiving the submission on November 19, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K183197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | April 04, 2019 |
| Days to Decision | 136 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 |