FDA Registration
Active
🇺🇸 United States
Canaveral Minimally Invasive Screw System
Reg #: 3011513267
·
FEI: 3011513267
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- FLOSPINE LLC
- Registration Number
- 3011513267
- FEI Number
- 3011513267
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3998 FAU Blvd, Suite 300
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141850
Owner / Operator
- Firm Name
- FloSpine LLC
- Operator Number
- 10048786
- Address
- 3998 FAU Blvd, Suite 300
- City
- Boca Raton
- State
- FL
- Postal Code
- 33431
- Country
- US
- Correspondent
- Peter M Harris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-02-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-02-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-02-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-02-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-02-27 |
Proprietary Names
Canaveral Minimally Invasive Screw System
Canaveral Pedicle Screw System
Canaveral Deformity Screw System
Establishment Types
Manufacture Medical Device