The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Variax 2 Foot System.
| Device ID | K170771 |
| 510k Number | K170771 |
| Device Name: | VariAx 2 Foot System |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Paul Nelson |
| Correspondent | Paul Nelson Stryker GmbH 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 | 2017-03-14 |
| Decision Date | 2017-05-08 |