BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    VersaLink™ Fixation System

    Reg #: 3012401682 · FEI: 3012401682 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PREMIA SPINE LTD.
    Registration Number
    3012401682
    FEI Number
    3012401682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Giborey Israel 7
    City
    Ramat Poleg, Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K182598

    Owner / Operator

    Firm Name
    Premia Spine Ltd.
    Operator Number
    10050301
    Address
    Giborey Israel 7
    City
    Ramat Poleg, Netanya
    State
    Central
    Postal Code
    4250407
    Country
    IL
    Correspondent
    Ron SACHER

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    VersaLink™ Fixation System

    Establishment Types

    Manufacture Medical Device