FDA Registration
Active
🇫🇷 France
Tornier Flex Shoulder System
Reg #: 3008388276
·
FEI: 3008388276
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TORNIER S.A.S
- Registration Number
- 3008388276
- FEI Number
- 3008388276
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 176 RUE LAVOISIER
- City
- Montbonnot Saint-Martin Isere
- Country
- FR
Regulatory Submissions
- 510(k) Number
- DEN220012
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 |
|---|---|---|---|---|---|
| Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis | QKW | Class 2 | Orthopedic | No | 2023-01-05 |
Proprietary Names
Tornier Flex Shoulder System
Tornier Pyrocarbon Humeral Head
Establishment Types
Manufacture Medical Device