The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade Gt/pf Nailing System, Imn Screws System, Imn Instruments System.
| Device ID | K180436 |
| 510k Number | K180436 |
| Device Name: | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker Trauma GmbH Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 |
| Contact | Heike Gustke |
| Correspondent | Heike Gustke Stryker Trauma GmbH Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-06-06 |
| Summary: | summary |