FDA Registration
Active
🇺🇸 United States
PRECICE UNYTE CoCr System
Reg #: 3006179046
·
FEI: 3006179046
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NuVasive Specialized Orthopedics, Inc.
- Registration Number
- 3006179046
- FEI Number
- 3006179046
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162927
Owner / Operator
- Firm Name
- NUVASIVE, INC.
- Operator Number
- 9036345
- Address
- 2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
- City
- Audubon
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Daniel S Paul
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-04-18 |
Proprietary Names
PRECICE UNYTE CoCr System
Establishment Types
Manufacture Medical Device