The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Axsos Proximal Lateral Tibia Long Plates.
| Device ID | K123403 |
| 510k Number | K123403 |
| Device Name: | AXSOS PROXIMAL LATERAL TIBIA LONG PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker Trauma AG 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi 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 | 2012-11-05 |
| Decision Date | 2013-03-20 |
| Summary: | summary |