BEUDAMED
    FDA Registration Active 🇫🇷 France

    NEOTIS implant for HTO, height 8 mm - porosity 30%; Catalog Number HTO2365XS8

    Reg #: 3004549189 · FEI: 3004051158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K130953

    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
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    NEOTIS implant for HTO, height 8 mm - porosity 30%; Catalog Number HTO2365XS8 NEOTIS implant for HTO, height 10 mm - porosity 45%; Catalog Number HTO2667XS10 NEOTIS implant for HTO, height 6 mm - porosity 30%; Catalog Number HTO2365XS6 NEOTIS implant for HTO, height 13 mm - porosity 45%; Catalog Number HTO2667XS13 NEOTIS implant for HTO, height 12 mm - porosity 45%; Catalog Number HTO2667XS12 NEOTIS implant for HTO, height 14 mm - porosity 45%; Catalog Number HTO2667XS14 NEOTIS implant for HTO, height 15 mm - porosity 45%; Catalog Number HTO2667XS15 NEOTIS implant for HTO, height 11 mm - porosity 45%; Catalog Number HTO2667XS11 NEOTIS implant for HTO, height 9 mm - porosity 45%; Catalog Number HTO2667XS9 NEOTIS implant for HTO, height 7 mm - porosity 30%; Catalog Number HTO2365XS7

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device