BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAIL FUSION

    Reg #: 3031024716 · FEI: 3031024716 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    SAIL FUSION
    Registration Number
    3031024716
    FEI Number
    3031024716
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2010 Jimmy Durante Blvd Ste 200
    City
    Del Mar
    State
    CA
    ZIP
    92014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232149

    Owner / Operator

    Firm Name
    SAIL Fusion
    Operator Number
    10090703
    Address
    2010 Jimmy Durante Blvd., Suite 200
    City
    Del Mar
    State
    CA
    Postal Code
    92014
    Country
    US
    Correspondent
    Alyson Ronald

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Tray, Surgical, Instrument FSM
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    BowTie™ SI Joint Fusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198