BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    SURGICAL FUSION TECHNOLOGIES GmbH

    Reg #: 3022518322 · FEI: 3022518322 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SURGICAL FUSION TECHNOLOGIES GmbH
    Registration Number
    3022518322
    FEI Number
    3022518322
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Wagistrasse 6
    City
    Schlieren Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K240288

    Owner / Operator

    Firm Name
    Surgical Fusion Technologies
    Operator Number
    10084998
    Address
    Wagistrasse 6
    City
    Schlieren
    State
    Zurich
    Postal Code
    8952
    Country
    CH
    Correspondent
    Felix A Kraeft

    US Agent

    Business Name
    GLW, Inc.
    Contact Name
    Arundhati Radhakrishnan
    Address
    930 Sylvan Ave Ste 125
    City
    Englewood Cliffs
    State
    NJ
    ZIP
    07632
    Country
    US
    Email
    [email protected]
    Phone
    917 4562939

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Screw, Fixation, Bone HWC
    Thoracolumbosacral Pedicle Screw System NKB
    Pin, Fixation, Smooth HTY

    Proprietary Names

    Handpiece Front Cover Sonotrode S-PI SF Push-in Anchor 3 Stopper S-PI-A3 Tray SF Push-in Anchor Portfolio Guide S-PI / W5 SF Push-in Anchor 1.6 Stopper S-PI-A1.6 SF Push-in Anchor 2.3 Stopper S-PI-A2.3 Drill PI-S-A2.3 Drill PI-S-A1.6 SupraFuser Generator Drill PI-S-A3 SupraFuser Handpiece SupraFuser B Ultrasonic Handpiece SupraFuser B Ultrasonic Generator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility