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 |