BEUDAMED
    FDA Registration Active 🇫🇷 France

    COULOT DECOLLETAGE

    Reg #: 3006217744 · FEI: 3006217744 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    23

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    Registration Details

    Registration Name
    COULOT DECOLLETAGE
    Registration Number
    3006217744
    FEI Number
    3006217744
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1, RUE NUNGESSER ET COLI
    City
    CHATELLERAULT Vienne
    Country
    FR

    Owner / Operator

    Firm Name
    COULOT DECOLLETAGE SAS
    Operator Number
    9093440
    Address
    89 South Commerce Way, Suite 990
    City
    Bethlehem
    State
    PA
    Postal Code
    18017
    Country
    US
    Correspondent
    Lisa Boyle

    US Agent

    Business Name
    COULOT DECOLLETAGE
    Contact Name
    Tania Shammo
    Address
    10325 58th Place
    City
    Kenosha
    State
    WI
    ZIP
    53144
    Country
    US
    Email
    [email protected]
    Phone
    262 2886450

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Rod, Fixation, Intramedullary And Accessories HSB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinous Process Plate PEK
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Plate, Fixation, Bone HRS
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Bone Fixation Cerclage, Sublaminar OWI
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Spinal Vertebral Body Replacement Device MQP
    Kit, Surgical Instrument, Disposable KDD
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Guide, Surgical, Instrument FZX
    Template HWT
    Cerclage, Fixation JDQ
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    ASTRA-OCT Spine System PERLA Novastep Airlock SAMARYS PCB Evolution Nexis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)