K232790 is an FDA 510(k) clearance for the KONG®-TL VBR System and KONG® C VBR System. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on April 4, 2024, 206 days after receiving the submission on September 11, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K232790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | April 04, 2024 |
| Days to Decision | 206 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 |