K121235 is an FDA 510(k) clearance for the LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on January 9, 2014, 625 days after receiving the submission on April 24, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K121235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2012 |
| Decision Date | January 09, 2014 |
| Days to Decision | 625 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 |