The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Modification To: Stryker Navigation System, Stryker Fluoroscopy System,virtual Fluoroscopy.
| Device ID | K012380 |
| 510k Number | K012380 |
| Device Name: | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe 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 | 2001-07-26 |
| Decision Date | 2001-12-03 |