BEUDAMED
    FDA Registration Active 🇫🇷 France

    Sterispine Pedicle Screw System

    Reg #: 3009509485 · FEI: 3009509485 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SAFE ORTHOPAEDICS SAS
    Registration Number
    3009509485
    FEI Number
    3009509485
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zone Dactivite De Montepy, 80 Rue De Montepy
    City
    Fleurieux-Sur-L'Arbresle Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K130632

    Owner / Operator

    Firm Name
    Safe Orthopaedics
    Operator Number
    10039164
    Address
    80 Rue de Montepy
    City
    69210
    State
    Rhone
    Postal Code
    69210
    Country
    FR
    Correspondent
    Nicolas Papillon

    US Agent

    Business Name
    XCIX DESIGN
    Contact Name
    Kyle ATWOOD
    Address
    11 W. 8900 S
    City
    Paradise
    State
    UT
    ZIP
    84328
    Country
    US
    Email
    [email protected]
    Phone
    435 5126808

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    Sterispine Pedicle Screw System

    Establishment Types

    Manufacture Medical Device