BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TransFasten - LSF (Lateral Sacroiliac Fusion System)

    Reg #: 3006082533 · FEI: 3006082533 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CAPTIVA SPINE, Inc.
    Registration Number
    3006082533
    FEI Number
    3006082533
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    967 N HIGHWAY A1A ALT STE 1
    City
    Jupiter
    State
    FL
    ZIP
    33477
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170475

    Owner / Operator

    Firm Name
    CAPTIVA SPINE
    Operator Number
    9096708
    Address
    967 Alternate A1A, SUITE 1
    City
    Jupiter
    State
    FL
    Postal Code
    33477
    Country
    US

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    TransFasten - LSF (Lateral Sacroiliac Fusion System)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility