ARTG 484025Verticale Fixation System - Spinal bone screw, non-biodegradable
ARTG ID: 484025 · Actis Medical Pty Ltd · Silony Medical GmbH · Class IIb · Started March 25, 2025
Good Name: Actis Medical Pty Ltd - Verticale Fixation System - Spinal bone screw, non-biodegradable
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 484025
- Start Date
- March 25, 2025
- Effective Date
- March 25, 2025
- Country
- Germany
- Address
- Leinfelder Strasse 60, Leinfelden-Echterdingen, 70771
System is intended to be used for surgical procedures with the objective of correction, immobilization and stabilization of the posterior pelvic ring, the lumbo-sacral and sacro-iliac region. To achieve the objective, it can be combined with the VERTICALE pedicle screw system. The devices are small, threaded, implantable rods with screw heads and drives made of non-bioabsorbable material. They are intended to be screwed into the spine to hold a stabilization device (e.g., rod, plate, tether) to bone for internal spinal fixation.
Access comprehensive regulatory information for Verticale Fixation System - Spinal bone screw, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 484025 and sponsored by Actis Medical Pty Ltd, manufactured by Silony Medical GmbH in Germany. The device registration started on March 25, 2025.
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.