BEUDAMED
    FDA Registration Active 🇫🇷 France

    ecoFIX® diameter 6.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV265CLA

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SCIENCE & BIO MATERIALS, S.B.M. SAS
    Registration Number
    3004549189
    FEI Number
    3004051158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZI DU MONGE
    City
    LOURDES Hautes-Pyrenees
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K231787

    Owner / Operator

    Firm Name
    SCIENCE & BIO MATERIALS
    Operator Number
    9063735
    Address
    S.B.M. SAS - ZI DU MONGE, --
    City
    Lourdes
    State
    Hautes-Pyrenees
    Postal Code
    65100
    Country
    FR
    Correspondent
    Anne - COSPIN

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI

    Proprietary Names

    ecoFIX® diameter 6.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV265CLA ecoFIX® Knotless diameter 5.5 mm Threaded Anchor ; Catalog Number EPAV355KNO ecoFIX® Knotless diameter 6.5 mm Threaded Anchor ; Catalog Number EPAV365KNO ecoFIX® Needle diameter 6.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV365CLA ecoFIX® diameter 4.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV245CLA ecoFIX® Needle diameter 5.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV355CLA ecoFIX® Needle diameter 4.5 mm Threaded Double-Loaded Suture Anchor System with Needles ; Catalog Number EPAV345CLA ecoFIX® Band diameter 4.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV545CLA ecoFIX® + diameter 5.5 mm Threaded Triple-Loaded Suture Anchor System ; Catalog Number EPAV455CLA ecoFIX® Band diameter 6.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV565CLA ecoFIX® Knotless diameter 4.5 mm Threaded Anchor ; Catalog Number EPAV345KNO ecoFIX® diameter 5.5 mm Threaded Double-Loaded Suture Anchor System ; Catalog Number EPAV255CLA ecoFIX® Band diameter 5.5 mm Threaded Double-Loaded Flat Suture Anchor System ; Catalog Number EPAV555CLA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device