The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Navigation System With Spinemap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, Spinemask Tracker.
| Device ID | K183196 |
| 510k Number | K183196 |
| Device Name: | Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Andrea Wallen-gerding |
| Correspondent | Andrea Wallen-gerding Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-02-14 |
| Summary: | summary |