BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FlexiGRAFT GraftLink

    Reg #: 3015724777 · FEI: 3015724777 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LifeNet Health
    Registration Number
    3015724777
    FEI Number
    3015724777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    845 Airtech Parkway, Suite 198
    City
    Plainfield
    State
    IN
    ZIP
    46168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041553

    Owner / Operator

    Firm Name
    LIFENET HEALTH
    Operator Number
    9079121
    Address
    1864 CONCERT DR., --
    City
    VIRGINIA BEACH
    State
    VA
    Postal Code
    23453
    Country
    US
    Correspondent
    MICHAEL A PLEW

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    FlexiGRAFT GraftLink FlexiGRAFT Sutured Lateral Ankle Tendon Construct FlexiGRAFT Connect FlexiGRAFT QuadLink FlexiGRAFT Connect EXT FlexiGRAFT GraftLink TS FlexiGRAFT DualLink

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)