K014263 is an FDA 510(k) clearance for the NEWGEN/UNIVERSAL MANDIBULAR SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 8, 2002, 71 days after receiving the submission on December 27, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K014263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2001 |
| Decision Date | March 08, 2002 |
| Days to Decision | 71 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 |