FDA Registration
Active
🇫🇷 France
Aequalis Reversed Shoulder Prosthesis
Reg #: 3000931034
·
FEI: 3000931034
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
3
Classifications
4
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
- K151293
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 |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-04-23 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2021-04-23 |
Proprietary Names
Aequalis Reversed Shoulder Prosthesis
Aequalis Ascend Flex Shoulder System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198