FDA Registration
Active
🇩🇪 Germany
Variax Distal Radius Line Extension
Reg #: 8010177
·
FEI: 3002821504
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K100271
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 | 2010-05-14 |
Proprietary Names
Variax Distal Radius Line Extension
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)