BEUDAMED
    FDA Registration Active 🇫🇷 France

    S.M.A.I.O

    Reg #: 3015383864 · FEI: 3015383864 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    95
    Establishment Types
    2
    Classifications
    19

    Registration Details

    Registration Name
    S.M.A.I.O
    Registration Number
    3015383864
    FEI Number
    3015383864
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Place Berthe Morisot, Parc Technologique
    City
    SAINT-PRIEST Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K253990

    Owner / Operator

    Firm Name
    S.M.A.I.O
    Operator Number
    10077967
    Address
    2 Place Berthe Morisot, Parc Technologique
    City
    SAINT-PRIEST
    State
    Auvergne-Rhone-Alpes
    Postal Code
    69800
    Country
    FR
    Correspondent
    Jean-Charles Roussouly

    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
    305 5999373

    Products

    Device Name Product Code
    Template HWT
    Awl HWJ
    Pusher, Socket HXO
    Bender HXW
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    System, X-Ray, Film Marking, Radiographic JAC
    Impactor HWA
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Compression HWN
    Gauge, Depth HTJ
    System, Image Processing, Radiological LLZ
    Wrench HXC
    Screwdriver HXX
    Tap, Bone HWX
    Bit, Drill HTW
    Probe HXB
    Osteotome HWM
    Tray, Surgical, Instrument FSM

    Proprietary Names

    L120mm rod template L60mm rod template L500mm rod template Short square awl Diameter 6 rod pusher Diameter 5.5 rod pusher Left diameter 6 rod coronal bender 7mm nut driver French bender Right diameter 6 rod sagittal bender Left diameter 6 rod sagittal bender Left diameter 5.5 rod sagittal bender Right diameter 6 rod coronal bender Left diameter 5.5 rod coronal bender Right diameter 5.5 rod coronal bender Right diameter 5.5 rod sagittal bender Ti K-rod for DePuy Synthes Ti K-ROD for Orthofix K-BALL KHEIRON Axial connector impactor Parallel connector holder 1/4" T-rachet handle Connector holder Sacral plate drilling guide Left 60deg S2 cap guide Short straight extension Tulip connector holder 7mm screwdriver Pedicle screw counter torque Sacral plate extension breaker 9mm nut driver Rod gripper Sacral screw holder Nut breaker sleeve 1/4" straight handle 1/4" T-handle 1/4" straight ratchet handle Distractor Sacral screw drill Nut breaker counter torque Long straight extension Plate holder Right 90deg S2 cap guide Left 90deg S2 cap guide Sacral connector holder Nut breaker Rod holder 1/4" straight medium handle Right 60deg S2 cap guide Axial connector holder Compressor Bicortical depth gauge Straight pedicle probe Straight feeler depth gauge Straight feeler Pedicle marker Curved pedicle probe KEOPS BALANCE ANALYZER 3D Derotation wrench Large Hudson nut driver Nut driver 3.5mm screwdriver Revision nut driver 4.5mm screwdriver Pedicle screwdriver Large Hudson pedicle screwdriver Post Nut Driver KHEIRON Spinal Fixation System, non-sterile implants Diameter 7.5 screw tap Diameter 6.5 screw tap Diameter 5.5 screw tap Diameter 4.5 screw tap Ti K-rod for Highridge Medical Straight osteotome Angulated osteotome Parallel connectors rack Connectors rack Extra parts rack #4 instruments tray - Dominos and sacral plates Sacral screws rack #3 instruments tray #2 pedicle screws rack Large implants tray Sacral plates rack #1 pedicle screws rack Rods set Implants tray #2 instruments tray Axial and tulip connectors rack Nuts rack #1 instruments tray Rack cover Tray cover KBA3D v2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device