K203282 is an FDA 510(k) clearance for the TECHFIT Patient-Specific Maxillofacial System. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Industrias Medicas Sampedro S.A.S (La Estrella, CO). The FDA issued a Cleared decision on May 19, 2021, 194 days after receiving the submission on November 6, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K203282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2020 |
| Decision Date | May 19, 2021 |
| Days to Decision | 194 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 |