FIBRALIGN CORPORATION

FDA Device Registration & Listing · Union City, CA, US · Registration 3013037653

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013037653
FEI Number
3013037653
Entity Name
FIBRALIGN CORPORATION
City/State/Country
Union City, CA, US
Establishment Address
32930 Alvrdo Niles Rd Ste 350, Union City, CA 94587, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fibralign Corporation (Owner Number: 10053092)
Owner / Operator Contact Address
32930 Alvarado-Niles Rd., Suite 350, Union City, CA 94587, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151083
PMA Number
N/A

All Registered Proprietary Names

BioBridge Collagen Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2016-10-31

Official Correspondent

Greg King

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fibralign Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3027383505 TYBR HEALTH, INC. Houston, TX, US
3005381997 LifeNet Health Virginia Bch, VA, US
1320894 CONMED CORPORATION Utica, NY, US
3010155661 Synergy Health Sterilisation UK Ltd Thorne Doncaster, GB
3012448339 STERI-TEK Fremont, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013037653. Last updated year: 2026. Please use registration number 3013037653 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.