The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Navigation System - Ct-based Hip Module, Model 6007-621-000.
| Device ID | K050615 |
| 510k Number | K050615 |
| Device Name: | STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Becky Ditty |
| Correspondent | Becky Ditty STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-09 |
| Decision Date | 2005-04-21 |
| Summary: | summary |