The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for T2 Tibial Nailing System.
| Device ID | K131365 |
| 510k Number | K131365 |
| Device Name: | T2 TIBIAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi Stryker Trauma AG 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 | 2013-05-13 |
| Decision Date | 2013-10-10 |
| Summary: | summary |