The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Leibinger Quik Disk Titanium Clamp System.
| Device ID | K993990 |
| 510k Number | K993990 |
| Device Name: | LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Kristyn R Kelley |
| Correspondent | Kristyn R Kelley STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-22 |
| Summary: | summary |