# Stryker Leibinger GmbH & Co. Kg (manufacturer, FREIBURG Baden-Wurttemberg, DE): 5 new FDA device listings, incl. drill, bone, powered

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Stryker Leibinger GmbH & Co. Kg |
| Owner / operator | Stryker Corp. |
| Role | Manufacturer |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | FREIBURG Baden-Wurttemberg, DE |
| New listings | 5 |
| Devices | Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Plate, Fixation, Bone; Screw, Fixation, Bone; Plate, Bone |
| Product codes | DZI, DZJ, HRS, HWC, JEY |
| Device classes | Class II |
| Medical specialties | Dental, Orthopedic |
| First new listing | 2026-07-08 |
| Latest new listing | 2026-10-12 |
| FDA registration number | 8010177 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.