FDA Registration
Active
🇫🇷 France
Blueprint Patient Specific Instrumentation
Reg #: 3000931034
·
FEI: 3000931034
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
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
- K211359
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 Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-12-06 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-12-06 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2021-12-06 |
Proprietary Names
Blueprint Patient Specific Instrumentation
Tornier Perform Patient-Matched Primary Reversed Glenoid
Shoulder iD Primary Reversed Glenoid
Shoulder iD
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device