K123786 is an FDA 510(k) clearance for the STRYKER UNIVERSAL ORBITAL FLOOR 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 April 9, 2013, 120 days after receiving the submission on December 10, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K123786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2012 |
| Decision Date | April 09, 2013 |
| Days to Decision | 120 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 |