FDA Registration
Active
🇺🇸 United States
NEXA CARPOMETACARPAL (CMI) IMPLANT
Reg #: 3004983210
·
FEI: 3004983210
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K060386
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, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2021-04-23 |
Proprietary Names
NEXA CARPOMETACARPAL (CMI) IMPLANT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility