K191997 is an FDA 510(k) clearance for the FAICO CMF System. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Faico Medical, LLC (Boca Raton, US). The FDA issued a Cleared decision on April 22, 2020, 271 days after receiving the submission on July 26, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K191997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2019 |
| Decision Date | April 22, 2020 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JEY - Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |