BEUDAMED
    FDA Registration Active 🇫🇷 France

    SIMAGEC

    Reg #: 3010462278 · FEI: 3010462278 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    SIMAGEC
    Registration Number
    3010462278
    FEI Number
    3010462278
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    54 avenue de la Plaine, Z.I.
    City
    ROUSSET CEDEX Bouches-du-Rhone
    Country
    FR

    Owner / Operator

    Firm Name
    SIMAGEC
    Operator Number
    10045012
    Address
    54 avenue de la Plaine, Z.I.
    City
    ROUSSET CEDEX
    State
    Bouches-du-Rhone
    Postal Code
    13106
    Country
    FR
    Correspondent
    Cedric GUILLOU

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Thoracolumbosacral Pedicle Screw System NKB
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Screw, Fixation, Bone HWC
    Staple, Fixation, Bone JDR
    Pin, Fixation, Smooth HTY
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Rod, Fixation, Intramedullary And Accessories HSB
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP
    Plate, Fixation, Bone HRS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Ankle, Uncemented, Non-Constrained NTG
    Spinal Vertebral Body Replacement Device MQP
    Instrument, Ligature Passing And Knot Tying HCF
    Passer, Wire, Orthopedic HXI
    Kit, Surgical Instrument, Disposable KDD
    Dressing, Wound, Hydrophilic NAC
    System, Facet Screw Spinal Device MRW
    Orthopedic Stereotaxic Instrument OLO
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Bone Fixation Cerclage, Sublaminar OWI
    Prosthesis, Tendon, Passive HXA
    Bit, Surgical GFG
    Guide, Surgical, Instrument FZX
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    SPINEVISION Smith&Nephew AMPLITUDE Smith and Nephew Duafit single use kit Neomis single use kit Neosys single use kit Cinesteam NEUROFRANCE Ecential Robotics Askorn VILEX CLARIANCE ECENTIAL ROBOTICS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)