Pure Global

Fixation anchor, soft-tissue, biodegradable - ARTG 375791

Access comprehensive regulatory information for Fixation anchor, soft-tissue, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 375791 and sponsored by Pureplay Orthopaedics, manufactured by Parcus Medical LLC in United States of America. The device registration started on October 05, 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
ARTG 375791
Class IIb
Fixation anchor, soft-tissue, biodegradable
ARTG ID: 375791
Good Name: Pureplay Orthopaedics - Fixation anchor, soft-tissue, biodegradable
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Intended Purpose

A device implanted into bone for the attachment of soft tissues either directly or via a suture and or tape attached to the device and functions as an alternative to drilling a hole in bone for passing a suture. This device is available in various designs and sizes and is made of materials such as advanced polymer, biodegradable material.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
375791
Start Date
October 05, 2021
Effective Date
October 05, 2021
Manufacturer
Country
United States of America
Address
6423 Parkland Drive, Sarasota, FL, 34243