The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for T2 Alpha Tibia Nailing System, Imn Screws System.
| Device ID | K193308 |
| 510k Number | K193308 |
| Device Name: | T2 Alpha Tibia Nailing System, IMN Screws System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker Trauma GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Sanja Jahr |
| Correspondent | Sanja Jahr Stryker Trauma 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 | 2019-11-29 |
| Decision Date | 2020-02-23 |