The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Axsos 3 Ti Locking Plate System Line Extension.
| Device ID | K133440 |
| 510k Number | K133440 |
| Device Name: | AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2013-12-18 |
| Summary: | summary |