BEUDAMED
    FDA Registration Active 🇫🇷 France

    FIXIT Knotless 6.5 mm threaded anchor single interference, Catalog Number EPAV265KNO

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K170868

    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

    FIXIT Knotless 6.5 mm threaded anchor single interference, Catalog Number EPAV265KNO FIXIT 6.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0065CLA FIXIT 5.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0055CLA FIXIT 4.5 mm threaded anchor mounted on screwdriver, Catalog Number EPA0047CLA FIXIT Knotless 5.5 mm threaded anchor single interference, Catalog Number EPAV255KNO ComposiTCP™ 6.5 mm Double Loaded MaxBraid™ Suture Anchor, Catalog Number 110026107 FIXIT Knotless 4.5 mm threaded anchor single interference, Catalog Number EPAV245KNO ComposiTCP™ 4.5 mm Double Loaded MaxBraid™ Suture Anchor, Catalog Number 110026105 ComposiTCP™ 5.5 mm Double Loaded MaxBraid™ Suture Anchor, Catalog Number 110026106

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device