The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Low Profile Orbital Floor Plate System.
| Device ID | K140978 |
| 510k Number | K140978 |
| Device Name: | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM |
| Classification | Plate, Bone |
| Applicant | OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Contact | Ally Baduel |
| Correspondent | Piedad Pena OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-16 |
| Decision Date | 2014-12-18 |
| Summary: | summary |