FDA Registration
Active
🇺🇸 United States
Tornier Perform Humeral System
Reg #: 3004983210
·
FEI: 3004983210
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- TORNIER Inc.
- Registration Number
- 3004983210
- FEI Number
- 3004983210
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4375 E. Park 30 Drive
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201315
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, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-04-23 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2021-04-23 |
Proprietary Names
Tornier Perform Humeral System
TORNIER PERFORM HUMERAL SYSTEM Sz 2 Plus stem
TORNIER PERFORM HUMERAL SYSTEM Sz 2 stem
TORNIER PERFORM HUMERAL SYSTEM Sz 3 Plus stem
TORNIER PERFORM HUMERAL SYSTEM Sz 3 stem
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility