BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ProMIS™ Fixation System

    Reg #: 3012401682 · FEI: 3012401682 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K150380

    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
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    ProMIS™ Fixation System

    Establishment Types

    Manufacture Medical Device