FDA Registration
Active
🇺🇸 United States
INFIGO MEDICAL
Reg #: 3022159082
·
FEI: 3022159082
·
Expires 2026
Products
15
Proprietary Names
4
Establishment Types
2
Classifications
15
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Registration Details
- Registration Name
- INFIGO MEDICAL
- Registration Number
- 3022159082
- FEI Number
- 3022159082
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 66 west flagler street suite 900
- City
- Miami
- State
- FL
- ZIP
- 33130
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240893
Owner / Operator
- Firm Name
- INFIGO MEDICAL
- Operator Number
- 10084742
- Address
- 66 west flagler street, suite 900
- City
- Miami
- State
- FL
- Postal Code
- 33130
- Country
- US
- Correspondent
- john ray
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2022-03-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-03-16 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2026-03-16 |
| Set, Hollow Mill | HWL | Class 1 | Orthopedic | No | 2026-03-16 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2023-09-25 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2023-09-25 |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2022-05-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-05-10 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-09-25 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-09-25 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-03-16 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2026-03-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-09-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-09-13 |
Proprietary Names
INFIGO INSTRUMENT
INFIGO INSTRUMENT TRAUMA
INFIGO SPINAL FIXATION SYSTEM
INFIGO TRAUMA SYSTEM
Establishment Types
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device