Data / Medical devices / United States / Alafair Biosciences, Inc.
Alafair Biosciences, Inc.: FDA-registered device maker in Austin, TX, United States, 10 510(k) clearances
Alafair Biosciences, Inc. is registered with the FDA (registration 3012669262) in Austin, TX, United States. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012669262
- Address
- 6101 W. Courtyard Dr. Ste 1-225, Austin, TX, United States, 78730
- Owner or operator
- Alafair Biosciences, Inc. (10052283)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 9, 2016
- Registered through
- 2026
- Brand names listed
- VersaCoat Nerve Protector, VersaCoat Tendon Protector, VersaWrap, VersaWrap Nerve Protector, VersaWrap Tendon Protector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cuff, Nerve | JXI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 22, 2025 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | JXI | Substantially Equivalent | Alafair Biosciences | accessdata.fda.gov |
| July 18, 2025 | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | OWW | Substantially Equivalent | Alafair Biosciences | accessdata.fda.gov |
| July 17, 2025 | K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | JXI | Substantially Equivalent | Alafair Biosciences | accessdata.fda.gov |
| June 14, 2024 | K240817 | VersaWrap | OWW | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| November 2, 2023 | K232029 | VersaWrap Nerve Protector | JXI | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| October 29, 2021 | K213163 | VersaWrap | FTM | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| March 9, 2021 | K203600 | VersaWrap | FTM | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| September 14, 2020 | K201631 | VersaWrap Nerve Protector | JXI | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| March 6, 2020 | K200311 | VersaWrap Tendon Protector | FTM | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
| June 10, 2016 | K160364 | VersaWrap Tendon Protector | OWW | Substantially Equivalent | Alafair Biosciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Nerve
- All makers of Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical
Updated July 22, 2025. 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.