The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Extremifuse System.
| Device ID | K130412 |
| 510k Number | K130412 |
| Device Name: | OSTEOMED EXTREMIFUSE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED 3885 ARAPAHO ROAD Addison, TX 75001 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-05-31 |
| Summary: | summary |