Pure Global

VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile - ARTG 462979

Access comprehensive regulatory information for VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462979 and sponsored by E4 Surgical Pty Ltd, manufactured by Silony Medical GmbH in Germany. The device registration started on September 27, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 462979
Class IIb
VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile
ARTG ID: 462979
Good Name: E4 Surgical Pty Ltd - VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

VERTICALE is a dorsal screw-rod fixation system for stabilizing the thoracic and lumbar spine. The VERTICALE System is made up of polyaxial, monoaxial, uniplanar, and iliac screws that are available as short head and long head screws (reduction screws). This range of pedicle screws, in either solid or cannulated and fenestrated versions, combined with 5.5-mm titanium or cobalt chromium rods to correct and stabilise degenerative spinal diseases.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
462979
Start Date
September 27, 2024
Effective Date
September 27, 2024
Manufacturer
Country
Germany
Address
Leinfelder Strasse 60, Leinfelden-Echterdingen, 70771