SURGICAL FUSION TECHNOLOGIES GmbH

FDA Device Registration & Listing · Schlieren Zurich, CH · Registration 3022518322

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022518322
FEI Number
3022518322
Entity Name
SURGICAL FUSION TECHNOLOGIES GmbH
City/State/Country
Schlieren Zurich, CH
Establishment Address
Wagistrasse 6, Schlieren Zurich 8952, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Surgical Fusion Technologies (Owner Number: 10084998)
Owner / Operator Contact Address
Wagistrasse 6, Schlieren, CH-ZH 8952, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 SF Push-in Anchor 2.3 SupraFuser B Ultrasonic Handpiece SupraFuser B Ultrasonic Generator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-04-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-04-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-04-11
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2024-04-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-04-25
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-04-25
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-04-25

Official Correspondent

Felix Kraeft

US Agent Details

Arundhati Radhakrishnan Business: GLW, Inc. Email: contact@glwmed.com Phone: (917) 4562939

Related Public Records

Same Entity

Surgical Fusion Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022518322. Last updated year: 2026. Please use registration number 3022518322 when referencing this establishment in official correspondence.
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