BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Orthosis, spinal pedicle fixation

    Reg #: 3009417901 · FEI: 3009417901 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SYNTHES GMBH
    Registration Number
    3009417901
    FEI Number
    3009417901
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Luzernstrasse 21
    City
    Zuchwil Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K111358

    Owner / Operator

    Firm Name
    SYNTHES GMBH / Synthes Produktions GmbH
    Operator Number
    9071542
    Address
    1301 Goshen Parkway
    City
    West Chester
    State
    PA
    Postal Code
    19380
    Country
    US

    Products

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

    Proprietary Names

    Orthosis, spinal pedicle fixation Orthosis, spondylolisthesis spinal fixation Thoracolumbosacral pedicle screw system Appliance, fixation, spinal intervertebral body APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility