FDA Registration
Active
🇺🇸 United States
REPUBLIC SPINE
Reg #: 3011796723
·
FEI: 3011796723
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- REPUBLIC SPINE
- Registration Number
- 3011796723
- FEI Number
- 3011796723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 NE Third Avenue, STE 120
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223096
Owner / Operator
- Firm Name
- Republic Spine
- Operator Number
- 10049873
- Address
- 100 NE Third Avenue, STE 120
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33301
- Country
- US
- Correspondent
- James Doulgeris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-11-02 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-11-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-01-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2020-01-08 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-08-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-08-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-12-17 |
Proprietary Names
Dark Star Deformity Pedicle Screw System
Restore Lumbar Interbody Fusion
Restore Cervical Interbody Fusion
Darkstar Navigation Instrument System
Republic Spine Dark Star Spinal System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device