Australia TGA ARTG record

Fixation anchor, soft-tissue, biodegradable

Australia TGA ARTG Registered Device · Pureplay Orthopaedics · Parcus Medical LLC · Class IIb · Started October 05, 2021

Good Name: Pureplay Orthopaedics - Fixation anchor, soft-tissue, biodegradable

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 05, 2021
Effective Date: October 05, 2021

Sponsor

Name: Pureplay Orthopaedics

Manufacturer

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

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.

About this record

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 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.