The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Upper-face Axs Screws And Mid-face Axs Screws.
| Device ID | K172572 |
| 510k Number | K172572 |
| Device Name: | Stryker Upper-Face AXS Screws And Mid-Face AXS Screws |
| Classification | Plate, Bone |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Contact | Jonathan Schell |
| Correspondent | Jonathan Schell Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2017-10-31 |
| Summary: | summary |