The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Smart Toe Ii, X Fuse.
| Device ID | K201715 |
| 510k Number | K201715 |
| Device Name: | Smart Toe II, X Fuse |
| Classification | Pin, Fixation, Smooth |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Jemin Dedania |
| Correspondent | Jemin Dedania Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-08-05 |