The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Stryker Variax 2 Mis Calcaneus.
| Device ID | K221346 |
| 510k Number | K221346 |
| Device Name: | Stryker VariAx 2 MIS Calcaneus |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Jonathan Schell |
| Correspondent | Jonathan Schell 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 | 2022-05-09 |
| Decision Date | 2022-07-08 |