The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Variax 2 System.
| Device ID | K140376 |
| 510k Number | K140376 |
| Device Name: | VARIAX 2 SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-04-03 |
| Summary: | summary |