The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade Gt/pf Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System.
| Device ID | K203819 |
| 510k Number | K203819 |
| Device Name: | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-29 |
| Decision Date | 2021-02-26 |