The following data is part of a premarket notification filed by Stryker with the FDA for T2 Femoral Nail Model 1825-xxxxcp, 1828-xxxxcp.
| Device ID | K112059 |
| 510k Number | K112059 |
| Device Name: | T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Stryker 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Valerie Giambanco |
| Correspondent | Valerie Giambanco Stryker 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-19 |
| Decision Date | 2011-08-08 |
| Summary: | summary |