K091807 is an FDA 510(k) clearance for the MEDPOR FIXATION SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on June 28, 2010, 375 days after receiving the submission on June 18, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K091807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2009 |
| Decision Date | June 28, 2010 |
| Days to Decision | 375 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 |