The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Axsos 3ti.
| Device ID | K153379 |
| 510k Number | K153379 |
| Device Name: | AxSOS 3Ti |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker GmbH Bohnackerweg 1 2545 Selzach, CH Ch 2545 |
| Contact | Saad Attiyah |
| Correspondent | Saad Attiyah Stryker GmbH Bohnackerweg 1 2545 Selzach, CH Ch 2545 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-05-26 |
| Summary: | summary |