FDA Registration
Active
🇺🇸 United States
HC BIOLOGICS LLC
Reg #: 3007604895
·
FEI: 3007604895
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- HC BIOLOGICS LLC
- Registration Number
- 3007604895
- FEI Number
- 3007604895
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1221 BRICKELL AVE, SUITE 900
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250092
Owner / Operator
- Firm Name
- HC BIOLOGICS LLC
- Operator Number
- 10054481
- Address
- 1221 BRICKELL AVE, SUITE 900
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
- Correspondent
- Husnu Ceylan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2026-01-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-07-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-07-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2026-05-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2026-05-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-05-14 |
Establishment Types
Manufacture Medical Device