K211892 is an FDA 510(k) clearance for the ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages). This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Arftx Medical, LLC (Jacksonville, US). The FDA issued a Cleared decision on October 6, 2022, 472 days after receiving the submission on June 21, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K211892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | October 06, 2022 |
| Days to Decision | 472 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 |