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OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis

Access comprehensive regulatory information for OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Zimmer Biomet Pty Ltd, manufactured by Biomet Orthopedics in United States of America. The device registration started on June 27, 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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Class III
Class III
OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis
Australia TGA ARTG Registered Device
Good Name: Zimmer Biomet Pty Ltd - OSS AVL Non-Modular Tibial Baseplate Long - Coated knee tibia prosthesis
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Intended Purpose

The OSS AVL non-modular tibial baseplate long is a component of the OSS Orthopaedic Salvage System intended for limb salvage procedures, resurfacing and revision applications. OSS System Indications: - Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. - Correction of varus, valgus, or posttraumatic deformity. - Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. - Ligament deficiencies. - Tumour resections. - Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. - Revision of previously failed total joint arthroplasty. - Trauma.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 27, 2024
Effective Date
June 27, 2024
Manufacturer
Country
United States of America
Address
56 East Bell Drive PO Box 587, Warsaw, IN, 46581