The following data is part of a premarket notification filed by Stryker Corporate with the FDA for Stryker Nav3i Platform.
| Device ID | K130874 |
| 510k Number | K130874 |
| Device Name: | STRYKER NAV3I PLATFORM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER CORPORATE BOETZINGER STR. 41 Freiburg, Baden-wuerttemberg, DE 79111 |
| Contact | Lilian Eckert |
| Correspondent | Lilian Eckert STRYKER CORPORATE BOETZINGER STR. 41 Freiburg, Baden-wuerttemberg, DE 79111 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-09-27 |
| Summary: | summary |