Data / Medical devices / United States / HC Biologics LLC
HC Biologics LLC: FDA-registered device maker in Miami, FL, United States, 2 510(k) clearances
HC Biologics LLC is registered with the FDA (registration 3007604895) in Miami, FL, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007604895
- Address
- 1221 Brickell Ave Suite 900, Miami, FL, United States, 33131
- Owner or operator
- HC BIOLOGICS LLC (10054481)
- Roles
- Manufacturer
- First device listed
- July 29, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | ODP | Substantially Equivalent | HC Biologics, LLC | accessdata.fda.gov |
| March 27, 2025 | K250092 | HC Biologics Osteopoint Spinal Fixation System | NKB | Substantially Equivalent | HC Biologics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Accessories, Fixation, Spinal Intervertebral Body
Updated April 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.