BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Paradigm Spine GmbH

    Reg #: 3005426761 · FEI: 3005426761 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Paradigm Spine GmbH
    Registration Number
    3005426761
    FEI Number
    3005426761
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Eisenbahnstrabe 84
    City
    Wurmlingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112595
    PMA Number
    P110008

    Owner / Operator

    Firm Name
    Companion Spine
    Operator Number
    10086759
    Address
    Immeuble le Bridge - 5 Allee des Acacias
    City
    Mérignac
    State
    Gironde
    Postal Code
    33700
    Country
    FR
    Correspondent
    Ratsamy Thevenin

    Products

    Device Name Product Code
    Prosthesis, Spinous Process Spacer/Plate NQO
    Appliance, Fixation, Spinal Interlaminal KWP
    Spinous Process Plate PEK

    Proprietary Names

    Coflex Interlaminar Technology Coflex-F Implant System Coflex-IF Cofix System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility