FDA Registration
Active
🇺🇸 United States
ARTFX MEDICAL LLC
Reg #: 3017435639
·
FEI: 3017435639
·
Expires 2026
Products
17
Proprietary Names
10
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- ARTFX MEDICAL LLC
- Registration Number
- 3017435639
- FEI Number
- 3017435639
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 50 n laura st 25th floor
- City
- JAX
- State
- FL
- ZIP
- 32202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240889
Owner / Operator
- Firm Name
- ARTFX MEDICAL LLC
- Operator Number
- 10077845
- Address
- 50 N laura st 25th floor
- City
- Jacksonville
- State
- FL
- Postal Code
- 32202
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2021-02-19 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2021-01-24 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-01-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-09-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-09-13 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2025-01-15 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-09-25 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-09-25 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-06-07 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-06-07 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-06-07 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-09-25 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2021-01-24 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-01-10 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2021-01-24 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2025-01-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-02-19 |
Proprietary Names
ARTFX SPINE INSTRUMENT
ARTFX Lumbar Cages
Artfx Trauma system
ARTFX ARTHROSCOPY
ARTFX SPINAL SYSTEM
ARTFX SPINAL FIXATION SYSTEM
ARTFX NAIL SYSTEM
ARTFX TRAUMA INSTRUMENT
ARTX Cervical Peek Cage
ARTFX CEMENT
Establishment Types
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only