The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Leibinger Cranial Fixation System.
| Device ID | K030378 |
| 510k Number | K030378 |
| Device Name: | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49087 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49087 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-03-20 |
| Summary: | summary |