The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Navigation System - Cranial Module, Model 6000-650-000.
| Device ID | K062640 |
| 510k Number | K062640 |
| Device Name: | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Beckey Ditty |
| Correspondent | Beckey Ditty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-06 |
| Decision Date | 2006-12-14 |
| Summary: | summary |