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Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable

Access comprehensive regulatory information for Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes, manufactured by Depuy Mitek (a Johnson & Johnson Company) in United States of America. The device registration started on July 29, 2016.

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 III
Class III
Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable
Australia TGA ARTG Registered Device
Good Name: Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Healix Advance BR Anchor with Permacord Suture - Fixation anchor, soft-tissue, biodegradable
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Intended Purpose

HEALIX ADVANCE BR Anchors with Permacord are indicated for use in soft tissue to bone fixation as follows: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow: Biceps Tendon Reattachment, Ulnar and Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 29, 2016
Effective Date
July 29, 2016
Manufacturer
Country
United States of America
Address
325 Paramount Drive, Raynham, MA, 02767