FDA Registration
Active
🇺🇸 United States
nex-D2 Posterior Fixation System
Reg #: 3010020754
·
FEI: 3010020754
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NEXT ORTHOSURGICAL
- Registration Number
- 3010020754
- FEI Number
- 3010020754
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3270 Corporate Vw Ste A
- City
- Vista
- State
- CA
- ZIP
- 92081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141291
Owner / Operator
- Firm Name
- Next Orthosurgical
- Operator Number
- 10042957
- Address
- 3270 Corporate View, Suite A
- City
- Vista
- State
- CA
- Postal Code
- 92081
- Country
- US
- Correspondent
- Misty Calkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-10-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-10-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-10-06 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-10-06 |
Proprietary Names
nex-D2 Posterior Fixation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device