BEUDAMED
    FDA Registration Active 🇫🇷 France

    SC MEDICA

    Reg #: 3033557813 · FEI: 3033557813 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    27
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SC MEDICA
    Registration Number
    3033557813
    FEI Number
    3033557813
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 Quai Kleber Tour Sebastopol
    City
    Strasbourg Bas-Rhin
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K252153

    Owner / Operator

    Firm Name
    SC MEDICA
    Operator Number
    10091466
    Address
    3 Quai Kleber Tour Sebastopol
    City
    Strasbourg
    State
    Bas-Rhin
    Postal Code
    67000
    Country
    FR
    Correspondent
    LAILA EL HAIMER

    US Agent

    Business Name
    ORTHOEX
    Contact Name
    Bret McClue
    Address
    7327 E Tierra Buena Ln
    City
    Scottsdale
    State
    AZ
    ZIP
    85260
    Country
    US
    Email
    [email protected]
    Phone
    480 3185805

    Products

    Device Name Product Code
    System, Facet Screw Spinal Device MRW
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    FFX Screw FFX Guide Pin Implant trial 11x 2.5 Facet chisel Impactor FFX Instruments Tray Facet Chisel Curette Screwdriver tip - screw D.3,5mm-L.18 FFX holder Screw guide left Interlaminar distractor Screwdriver tip - screw D.3,5mm-L.22 Handle Implant trial 11x 3 Rasp Mallet Working tube Drill - screw D.3,5mm-L.20 impactor Drill - screw D.3,5mm-L.22 Drill - screw D.3,5mm-L.18 Screwdriver tip - screw D.3,5mm-L.20 FFX Holder Screw guide right Graft holder

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device