Pure Global

Soft-tissue anchor, non-bioabsorbable - ARTG 467726

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 467726 and sponsored by Pureplay Orthopaedics, manufactured by Parcus Medical LLC in United States of America. The device registration started on November 08, 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.

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TGA ARTG Official Data
Class IIb
ARTG 467726
Class IIb
Soft-tissue anchor, non-bioabsorbable
ARTG ID: 467726
Good Name: Pureplay Orthopaedics - Soft-tissue anchor, non-bioabsorbable
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Intended Purpose

Device indicated for attachment of soft tissue to bone. These products are intended for use in the shoulder, foot/ankle and knee. The suture anchors are manufactured from PEEK or a biocmposite material of ฮฒTCP and PLGA.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467726
Start Date
November 08, 2024
Effective Date
November 08, 2024
Manufacturer
Country
United States of America
Address
6423 Parkland Drive, Sarasota, FL, 34243