BEUDAMED
    FDA Registration Active 🇫🇷 France

    OTIS self-tapping locking screw - length 36 mm, Catalog Number EVO9066036

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    2

    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
    K100604

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS

    Proprietary Names

    OTIS self-tapping locking screw - length 36 mm, Catalog Number EVO9066036 OTIS self-tapping locking screw - length 50 mm, Catalog Number EVO9066050 OTIS self-tapping locking screw - length 60 mm, Catalog Number EVO9066060 OTIS self-tapping locking screw - length 30 mm, Catalog Number EVO9066030 OTIS self-tapping locking screw - length 55 mm, Catalog Number EVO9066055 OTIS self-tapping locking screw - length 27 mm, Catalog Number EVO9066027 OTIS self-tapping locking screw - length 65 mm, Catalog Number EVO9066065 OTIS self-tapping locking screw - length 39 mm, Catalog Number EVO9066039 OTIS self-tapping locking screw - length 70 mm, Catalog Number EVO9066070 OTIS self-tapping locking screw - length 45 mm, Catalog Number EVO9066045 OTIS self-tapping locking screw - length 42 mm, Catalog Number EVO9066042 OTIS self-tapping locking screw - length 33 mm, Catalog Number EVO9066033

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device