FDA Registration
Active
🇩🇪 Germany
STRYKER LEIBINGER GMBH & CO. KG
Reg #: 8010177
·
FEI: 3002821504
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
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
- K241171
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 |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-07-26 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-07-26 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-07-26 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2024-07-26 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device