FDA Registration
Active
🇺🇸 United States
PreCept Spinal System
Reg #: 3009144915
·
FEI: 3009144915
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NUVASIVE, INC.
- Registration Number
- 3009144915
- FEI Number
- 3009144915
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- City View Plaza 1 Suites 116 & 117, #48 Rd 165 Km 1.2
- City
- Guaynabo
- State
- PR
- ZIP
- 00968
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102514
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-06-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2012-06-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2012-06-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-06-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-06-19 |
Proprietary Names
PreCept Spinal System
Establishment Types
Manufacture Medical Device