K071612 is an FDA 510(k) clearance for the MODUS TRILOCK 2.0/2.3/2.5. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Medartis AG (San Diego, US). The FDA issued a Cleared decision on September 11, 2007, 90 days after receiving the submission on June 13, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K071612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2007 |
| Decision Date | September 11, 2007 |
| Days to Decision | 90 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 |