The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Axsos Locking Plate System.
| Device ID | K112926 |
| 510k Number | K112926 |
| Device Name: | AXSOS LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Kelly Kucharczyk |
| Correspondent | Kelly Kucharczyk STRYKER CORP. 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 | 2011-10-03 |
| Decision Date | 2011-12-19 |
| Summary: | summary |