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Acetabular shell - ARTG 462134

Access comprehensive regulatory information for Acetabular shell in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462134 and sponsored by Signature Orthopaedics Pty Ltd, manufactured by Signature Orthopaedics Pty Ltd in Australia. The device registration started on September 10, 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 I
ARTG 462134
Class I
Acetabular shell
ARTG ID: 462134
Good Name: Signature Orthopaedics Pty Ltd - Acetabular shell
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Intended Purpose

Signature Orthopaedics' hip replacement range is intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis - Correction of functional deformity including congenital hip dysplasia - Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - Dislocation Risks (when used with SignaSure range)

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
462134
Start Date
September 10, 2024
Effective Date
September 10, 2024
Manufacturer
Country
Australia
Address
7 Sirius Road, LANE COVE WEST, NSW, 2066