The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for T2 Icf.
| Device ID | K193366 |
| 510k Number | K193366 |
| Device Name: | T2 ICF |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-03-20 |