K192747 is an FDA 510(k) clearance for the Yxoss CBR®. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Reoss GmbH (Filderstadt, DE). The FDA issued a Cleared decision on June 17, 2020, 261 days after receiving the submission on September 30, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K192747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | June 17, 2020 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY - Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |