ARTG 468367Soft-tissue anchor, non-bioabsorbable
ARTG ID: 468367 · Actis Medical Pty Ltd · Paragon 28 Inc · Class IIb · Started November 13, 2024
Good Name: Actis Medical Pty Ltd - Soft-tissue anchor, non-bioabsorbable
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 468367
- Start Date
- November 13, 2024
- Effective Date
- November 13, 2024
- Name
- Paragon 28 Inc
- Country
- United States of America
- Address
- 14445 Grasslands Drive, Englewood, Colorado, 80112
The R3ACT™ Stabilization System is a fixation device comprised of a titanium alloy screw, UHMWPE suture, and a polyurethane component. The R3ACT™ is implanted as a rigid screw-type anchor and transitions to engage the internal UHMWPE suture loop and bumper to allow for dynamic diastatic motion and fibular rotation in a semi constrained fashion. It is offered in varying sizes to accommodate a variety of applications and variation in anatomy. The suture loop is non-absorbable. The R3ACT™ Stabilization System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with ankle fractures.
Access comprehensive regulatory information for Soft-tissue anchor, non-bioabsorbable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 468367 and sponsored by Actis Medical Pty Ltd, manufactured by Paragon 28 Inc in United States of America. The device registration started on November 13, 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.