The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Axsos 3 Ti.
| Device ID | K172350 |
| 510k Number | K172350 |
| Device Name: | AxSOS 3 Ti |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker GmbH Bohnackerweg 1 Selzach, CH 2545 |
| Contact | Kemine Hale |
| Correspondent | Kemine Hale Stryker GmbH Bohnackerweg 1 Selzach, 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 | 2017-08-03 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327283723 | K172350 | 000 |