The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (gtn),t2 Ankle Arthrodesis Nail,t2 Arthrodesis Nail System.
| Device ID | K200880 |
| 510k Number | K200880 |
| Device Name: | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Jackie Perri |
| Correspondent | Jackie Perri 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 | 2020-04-02 |
| Decision Date | 2020-07-01 |