FDA Registration
Active
🇩🇪 Germany
Stryker Resorbable Fixation System
Reg #: 8010177
·
FEI: 3002821504
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- STRYKER LEIBINGER GMBH & CO. KG
- Registration Number
- 8010177
- FEI Number
- 3002821504
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BOTZINGER STRASSE 39-41
- City
- FREIBURG Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K113109
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-01-17 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2012-01-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-01-17 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2012-01-17 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2012-01-17 |
Proprietary Names
Stryker Resorbable Fixation System
Delta System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device