K211320 is an FDA 510(k) clearance for the CAPRI Corpectomy Cage System. This device is classified as a Spinal Vertebral Body Replacement Device - Cervical (Class II - Special Controls, product code PLR).
Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 24, 2022, 300 days after receiving the submission on April 30, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060. Vertebral Body Replacement In The Cervical Spine..
| 510(k) Number | K211320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2021 |
| Decision Date | February 24, 2022 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLR — Spinal Vertebral Body Replacement Device - Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
| Definition | Vertebral Body Replacement In The Cervical Spine. |