The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Imf Screw.
| Device ID | K151195 |
| 510k Number | K151195 |
| Device Name: | OsteoMed IMF Screw |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-09-21 |
| Summary: | summary |