BEUDAMED
    FDA Registration Active 🇫🇷 France

    PLUS Pivot Link Universal System

    Reg #: 3003526896 · FEI: 3003526896 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SPINEVISION SAS
    Registration Number
    3003526896
    FEI Number
    3003526896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Rue De La Renaissance
    City
    Antony Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K033508

    Owner / Operator

    Firm Name
    SPINEVISION SAS
    Operator Number
    9048013
    Address
    3 rue de la Renaissance
    City
    Antony
    State
    Paris
    Postal Code
    F-92160
    Country
    FR
    Correspondent
    Quang TRAN

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    PLUS Pivot Link Universal System PLUS Pivot Link Universal System (U1-L404T) PLUS Pivot Link Universal System (U1-A127C) PLUS Pivot Link Universal System (U1-L310T) PLUS Pivot Link Universal System (U1-TRAY115) PLUS Pivot Link Universal System (U1-ID) PLUS Pivot Link Universal System (U1-L303T) PLUS Pivot Link Universal System (U1-A328) PLUS Pivot Link Universal System (U1-L403T) PLUS Pivot Link Universal System (SD-IDPP) PLUS Pivot Link Universal System (SD-A411LSH) PLUS Pivot Link Universal System (U1-TRAY113) PLUS Pivot Link Universal System (U1-TRAY119) PLUS Pivot Link Universal System (SD-IDC) PLUS Pivot Link Universal System (U1-A329) PLUS Pivot Link Universal System (U1-A218S) PLUS Pivot Link Universal System (U1-TRAY117) PLUS Pivot Link Universal System (U1-TRAY111) PLUS Pivot Link Universal System (U1-TRAY112) PLUS Pivot Link Universal System (U1-A214S) PLUS Pivot Link Universal System (SD-TRAY112) PLUS Pivot Link Universal System (SD-TRAY111) PLUS Pivot Link Universal System (U1-A216) PLUS Pivot Link Universal System (U1-TRAY114) PLUS Pivot Link Universal System (U1-RACKHOOK) PLUS Pivot Link Universal System (U1-TRAY118) PLUS Pivot Link Universal System (U1-RACKVIS1) PLUS Pivot Link Universal System (U1-RACKVIS2) PLUS Pivot Link Universal System (U1-RACKCLIP) PLUS Pivot Link Universal System (U1-RACKIS) PLUS Pivot Link Universal System (SD-TRAY113)

    Establishment Types

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