Data / Medical devices / United States / Fibralign Corporation
Fibralign Corporation: FDA-registered device maker in Union City, CA, United States, 1 510(k) clearance
Fibralign Corporation is registered with the FDA (registration 3013037653) in Union City, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 8, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013037653
- Address
- 32930 Alvrdo Niles Rd Ste 350, Union City, CA, United States, 94587
- Owner or operator
- Fibralign Corporation (10053092)
- Roles
- Manufacturer
- First device listed
- October 31, 2016
- Registered through
- 2026
- Brand names listed
- BioBridge Collagen Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 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 |
|---|---|---|---|---|---|---|
| January 8, 2016 | K151083 | BioBridge Collagen Matrix | OWY | Substantially Equivalent | Fibralign Corporation | accessdata.fda.gov |
Compare with other makers
Updated January 8, 2016. 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.