K232889 is an FDA 510(k) clearance for the METICULY Patient-specific titanium maxillofacial mesh implant. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Meticuly Co., Ltd. (Bangkok, TH). The FDA issued a Cleared decision on April 30, 2024, 225 days after receiving the submission on September 18, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K232889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2023 |
| Decision Date | April 30, 2024 |
| Days to Decision | 225 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 |