FDA Registration
Active
🇫🇷 France
Cement Restrictor
Reg #: 3000931034
·
FEI: 3000931034
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Tornier S.A.S.
- Registration Number
- 3000931034
- FEI Number
- 3000931034
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 161 rue Lavoisier
- City
- Montbonnot Saint-Martin Isere
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K061824
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 |
|---|---|---|---|---|---|
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2021-04-22 |
Proprietary Names
Cement Restrictor
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device