The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Stryker Navigation System-knee Module.
| Device ID | K022579 |
| 510k Number | K022579 |
| Device Name: | STRYKER NAVIGATION SYSTEM-KNEE MODULE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Kelli J Bitterburg |
| Correspondent | Kelli J Bitterburg STRYKER LEIBINGER 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 | 2002-08-05 |
| Decision Date | 2003-06-02 |
| Summary: | summary |