FDA Registration
Active
🇺🇸 United States
Quantum Spinal Fixation System
Reg #: 3005031160
·
FEI: 3005031160
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Xtant Medical Holdings, Inc.
- Registration Number
- 3005031160
- FEI Number
- 3005031160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 664 Cruiser Lane
- City
- Belgrade
- State
- MT
- ZIP
- 59714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041167
Owner / Operator
- Firm Name
- Xtant Medical Holdings, Inc.
- Operator Number
- 10028385
- Address
- 664 Cruiser Lane
- City
- Belgrade
- State
- MT
- Postal Code
- 59714
- Country
- US
- Correspondent
- Rebecca Lennemann
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-01-08 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-01-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-01-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-01-08 |
Proprietary Names
Quantum Spinal Fixation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198