ARTG 462979VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile
ARTG ID: 462979 · E4 Surgical Pty Ltd · Silony Medical GmbH · Class IIb · Started September 27, 2024
Good Name: E4 Surgical Pty Ltd - VERTICALE Open Screw Rod System - Bone-screw internal spinal fixation system, sterile
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 462979
- Start Date
- September 27, 2024
- Effective Date
- September 27, 2024
- Country
- Germany
- Address
- Leinfelder Strasse 60, Leinfelden-Echterdingen, 70771
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.
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.