K132519 is an FDA 510(k) clearance for the STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT. 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 December 6, 2013, 116 days after receiving the submission on August 12, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K132519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2013 |
| Decision Date | December 06, 2013 |
| Days to Decision | 116 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 |