K122890 is an FDA 510(k) clearance for the INION CPS ORBITAL PLATES. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on January 29, 2013, 131 days after receiving the submission on September 20, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K122890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2012 |
| Decision Date | January 29, 2013 |
| Days to Decision | 131 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 |