K992683 is an FDA 510(k) clearance for the MODUS 2.5 MANDIBULAR TRAUMA SET. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Medartis AG (Waltham, US). The FDA issued a Cleared decision on November 24, 1999, 106 days after receiving the submission on August 10, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K992683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1999 |
| Decision Date | November 24, 1999 |
| Days to Decision | 106 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 |