The following data is part of a premarket notification filed by Stryker Corporate with the FDA for Navigated Xia 4.5 Polyaxial Screwdriver.
| Device ID | K143597 |
| 510k Number | K143597 |
| Device Name: | Navigated XIA 4.5 Polyaxial Screwdriver |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | STRYKER CORPORATE BOETZINGER STR.41 Freiburg, DE 79111 |
| Contact | Becky Ditty |
| Correspondent | Becky Ditty STRYKER CORPORATE 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-09-04 |
| Summary: | summary |