K103778 is an FDA 510(k) clearance for the LEFORTE NEURO SYSTEM BONE PLATE. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Jeil Medical Corporation (Norcross, US). The FDA issued a Cleared decision on January 26, 2011, 30 days after receiving the submission on December 27, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K103778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2010 |
| Decision Date | January 26, 2011 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |