FDA Registration
Active
🇺🇸 United States
G-5 FLORIDA LLC
Reg #: 1066368
·
FEI: 3003346235
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- G-5 FLORIDA LLC
- Registration Number
- 1066368
- FEI Number
- 3003346235
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4801 Dawin Rd
- City
- JAX
- State
- FL
- ZIP
- 32207
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171863
Owner / Operator
- Firm Name
- G-5 Florida LLC
- Operator Number
- 9045425
- Address
- 4801 DAWIN RD., --
- City
- Jacksonville
- State
- FL
- Postal Code
- 32207
- Country
- US
- Correspondent
- Dean Tulumaris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-01-09 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-05-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-05-12 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2018-03-22 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2021-07-20 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2023-06-30 |
Proprietary Names
NexFlex
LineSider Spinal System
Anjon Bremer Halo System
Next Science Xperience
OsteoFlo 5cc Tube
OsteoFlo 1cc Syringe
OsteoFlo 5cc Syringe
OsteoFlo 10cc Tube
OsteoFlo 2.5cc Syringe
OsteoFlo 10cc Syringe
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device