The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Axsos 3 Ti Locking Plate System.
Device ID | K141121 |
510k Number | K141121 |
Device Name: | AXSOS 3 TI LOCKING PLATE SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Elijah Wreh |
Correspondent | Elijah Wreh Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-30 |
Decision Date | 2014-06-20 |
Summary: | summary |