Australia TGA ARTG record

Soft-tissue anchor, non-bioabsorbable

Australia TGA ARTG Registered Device · Pureplay Orthopaedics · Parcus Medical LLC · Class IIb · Started October 07, 2021

Good Name: Pureplay Orthopaedics - Soft-tissue anchor, non-bioabsorbable

Device classification

Risk Class: Class IIb
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: October 07, 2021
Effective Date: October 07, 2021

Sponsor

Name: Pureplay Orthopaedics

Manufacturer

Name: Parcus Medical LLC
Country: United States of America
Address: 6423 Parkland Drive, Sarasota, FL, 34243

Intended purpose

Adjustable suture construct with two stainless steel buttons. The oblong shaped button spans a drilled tunnel for medial cortex fixation and a stainless steel “top hat” shaped button for lateral cortex fixation. Creating stability in the ankle joint

About this record

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 sponsored by Pureplay Orthopaedics, manufactured by Parcus Medical LLC in United States of America. The device registration started on October 07, 2021.

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.