Pure Global

Soft-tissue anchor, non-bioabsorbable

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Soft-tissue anchor, non-bioabsorbable
Australia TGA ARTG Registered Device
Good Name: Pureplay Orthopaedics - Soft-tissue anchor, non-bioabsorbable
Pure Global
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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 โ€œtop hatโ€ shaped button for lateral cortex fixation. Creating stability in the ankle joint

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
Manufacturer
Country
United States of America
Address
6423 Parkland Drive, Sarasota, FL, 34243