The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Variax 2 One-third Tubular Plating System.
| Device ID | K151879 |
| 510k Number | K151879 |
| Device Name: | VariAx 2 One-Third Tubular Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER GMBH PROF. KUENTSCHER STR. 1-5 Schoenkirchen, DE D-24232 |
| Contact | Heike Gustke |
| Correspondent | Heike Gustke STRYKER GMBH PROF. KUENTSCHER STR. 1-5 Schoenkirchen, DE D-24232 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-08-06 |
| Summary: | summary |