The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed 2.0 Locking Plates And Screws.
| Device ID | K030448 |
| 510k Number | K030448 |
| Device Name: | OSTEOMED 2.0 LOCKING PLATES AND SCREWS |
| Classification | Plate, Bone |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Dawn T Holdeman |
| Correspondent | Dawn T Holdeman OSTEOMED L.P. 3885 ARAPAHO RD. 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 | 2003-02-11 |
| Decision Date | 2003-05-09 |
| Summary: | summary |