The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Variax Distal Radius Plating System, Variax 2 System.
| Device ID | K162841 |
| 510k Number | K162841 |
| Device Name: | VariAx Distal Radius Plating System, VariAx 2 System |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Irene Bacalocostantis |
| Correspondent | Irene Bacalocostantis 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 | 2016-10-11 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327314625 | K162841 | 000 |
| 04546540716040 | K162841 | 000 |
| 07613154585113 | K162841 | 000 |
| 07613327314496 | K162841 | 000 |
| 07613327314502 | K162841 | 000 |
| 07613327314519 | K162841 | 000 |
| 07613327314526 | K162841 | 000 |
| 07613327314533 | K162841 | 000 |
| 07613327314540 | K162841 | 000 |
| 07613327314557 | K162841 | 000 |
| 07613327314571 | K162841 | 000 |
| 07613327314588 | K162841 | 000 |
| 07613327314595 | K162841 | 000 |
| 07613327314601 | K162841 | 000 |
| 04546540696953 | K162841 | 000 |