BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioBridge Collagen Matrix

    Reg #: 3013037653 · FEI: 3013037653 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FIBRALIGN CORPORATION
    Registration Number
    3013037653
    FEI Number
    3013037653
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    32930 Alvrdo Niles Rd Ste 350
    City
    Union City
    State
    CA
    ZIP
    94587
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151083

    Owner / Operator

    Firm Name
    Fibralign Corporation
    Operator Number
    10053092
    Address
    32930 Alvarado-Niles Rd., Suite 350
    City
    Union City
    State
    CA
    Postal Code
    94587
    Country
    US
    Correspondent
    Greg King

    Products

    Device Name Product Code
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY

    Proprietary Names

    BioBridge Collagen Matrix

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198