The following data is part of a premarket notification filed by Stryker Leibinger Gmbh with the FDA for Variax Distal Radius Plating System.
| Device ID | K133974 |
| 510k Number | K133974 |
| Device Name: | VARIAX DISTAL RADIUS PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER LEIBINGER GMBH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Elijah N Wreh |
| Correspondent | Elijah N Wreh STRYKER LEIBINGER 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 | 2013-12-26 |
| Decision Date | 2014-03-24 |
| Summary: | summary |