BEUDAMED
    FDA Registration Active 🇫🇷 France

    SAFE ORTHOPAEDICS SAS

    Reg #: 3009509485 · FEI: 3009509485 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    SAFE ORTHOPAEDICS SAS
    Registration Number
    3009509485
    FEI Number
    3009509485
    Status
    Active
    Expiry Year
    2026
    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
    K121299

    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
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Instrument, Bending Or Contouring HXP
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Tamp HXG
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Instrument, Compression HWN

    Proprietary Names

    ROD INTRODUCER KIT Sterispine Pedicle Screw System ROD BENDER FOR 5.5MM ROD SteriSpine VA SYNTH™ Plus MEDINAUT Plus KIT OF CURVED LUMBAR CAGE RACKING COMPRESSION PLIER KIT STERISPINE LC Lumbar Interbody Device SteriSpine Pedicle screw system

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device