The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Fixation System.
| Device ID | K091807 |
| 510k Number | K091807 |
| Device Name: | MEDPOR FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Jerri Mann |
| Correspondent | Jerri Mann POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2010-06-28 |
| Summary: | summary |