The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for Stryker Sonicpin System, Stryker Sonicanchor System.
| Device ID | K143063 |
| 510k Number | K143063 |
| Device Name: | Stryker SonicPin System, Stryker SonicAnchor System |
| Classification | Pin, Fixation, Smooth |
| Applicant | STRYKER TRAUMA GMBH 325 Corporate Mahwah, NJ 07430 |
| Contact | Estela Celi |
| Correspondent | Estela Celi STRYKER TRAUMA GMBH 325 Corporate Mahwah, NJ 07430 |
| Product Code | HTY |
| Subsequent Product Code | GAT |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-24 |
| Decision Date | 2015-01-27 |
| Summary: | summary |