The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Navigation System With Cranialmap Software Application, Stryker Cranialmap Planning Software Application, Stryker Cranialmask Tracker.
| Device ID | K162929 |
| 510k Number | K162929 |
| Device Name: | Stryker Navigation System With CranialMap Software Application, Stryker CranialMap Planning Software Application, Stryker CranialMask Tracker |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Stryker Corporation Botzinger Strasse 41 Freiburg Baden-wurttemberg, DE D-79111 |
| Contact | Brittney M. Larsen |
| Correspondent | Brittney M. Larsen Stryker Corporation Botzinger Strasse 41 Freiburg Baden-wurttemberg, DE D-79111 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-19 |
| Decision Date | 2017-02-22 |
| Summary: | summary |