The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Asnis Jfx System.
| Device ID | K153154 |
| 510k Number | K153154 |
| Device Name: | Asnis JFX System |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Garry T. Hayeck |
| Correspondent | Garry T. Hayeck Stryker Trauma AG 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 | 2015-11-02 |
| Decision Date | 2015-12-28 |