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 |