BEUDAMED
    FDA Registration Active 🇫🇷 France

    DXTEND MBLOC HUM EPI

    Reg #: 3002807295 · FEI: 3002807295 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IONISOS
    Registration Number
    3002807295
    FEI Number
    3002807295
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Z.A de L Aubree
    City
    SABLE-SUR-SARTHE
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K062250

    Owner / Operator

    Firm Name
    EPIONE BIDCO
    Operator Number
    10042490
    Address
    415 allee de Frenes, bat Squale
    City
    LIMONEST
    State
    Rhone
    Postal Code
    69760
    Country
    FR
    Correspondent
    Alexandra Basset

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7131159

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    DXTEND MBLOC HUM EPI DELTA SHOULDER DXTEND METAGLENE DXTEND SCREW LOCK DXTEND HUMERAL SPACER DXTEND STAND PE CUP DXTEND IMP HUM CIM DXTEND SCREW NO LOCK DXTEND GLENOSPHERE DXTEND CTA HEAD DXTEND RETENT PE CUP

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)