The following data is part of a premarket notification filed by Stryker Leibinger with the FDA for Stryker Leibinger Universal Distal Radius System.
| Device ID | K040022 |
| 510k Number | K040022 |
| Device Name: | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Wade T Rutkoskie |
| Correspondent | Wade T Rutkoskie STRYKER LEIBINGER 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-07 |
| Decision Date | 2004-03-12 |
| Summary: | summary |