The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Navigation System-spine & Fluoroscopy Modules.
| Device ID | K003111 |
| 510k Number | K003111 |
| Device Name: | STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Nicole Petty |
| Correspondent | Nicole Petty 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 | 2000-10-04 |
| Decision Date | 2001-01-04 |