The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Variax 2 Wrist Fusion System.
| Device ID | K151178 |
| 510k Number | K151178 |
| Device Name: | VariAx 2 Wrist Fusion System |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker Trauma AG PROF.-KUNTSCHER-STR. 1-5 Schoenkirchen, DE 24232 |
| Contact | Dr. Heike Gustke |
| Correspondent | Dr. Heike Gustke Stryker Trauma AG PROF.-KUNTSCHER-STR. 1-5 Schoenkirchen, DE 24232 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-06-24 |
| Summary: | summary |