The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Gamma4 System, Gamma3 System, Imn Screws System, T2 Tibial Nailing System.
| Device ID | K213328 |
| 510k Number | K213328 |
| Device Name: | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Cindy Leon |
| Correspondent | Cindy Leon 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 | 2021-10-05 |
| Decision Date | 2022-02-11 |