BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

    Reg #: 3009417901 · FEI: 3009417901 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K162358

    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
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility