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PMT Halo Cervical spine immobilization system - Cervical spine immobilization system, single-use - ARTG 358130

Access comprehensive regulatory information for PMT Halo Cervical spine immobilization system - Cervical spine immobilization system, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 358130 and sponsored by Massons Healthcare, manufactured by PMT Corporation in United States of America. The device registration started on March 29, 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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Class IIb
ARTG 358130
Class IIb
PMT Halo Cervical spine immobilization system - Cervical spine immobilization system, single-use
ARTG ID: 358130
Good Name: Massons Healthcare - PMT Halo Cervical spine immobilization system - Cervical spine immobilization system, single-use
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Intended Purpose

Orthopaedic device designed to immobilise the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. For use in traumatic or chronic disorders requiring traction along the cervical spine to align the vertebral structures (reduce deformities), maintain reduction, or provide stabilization. Indications include cervical spine trauma or surgery. A frame that encompasses the whole or part of the cervical region including the head. The device is body worn.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
358130
Start Date
March 29, 2021
Effective Date
March 29, 2021
Manufacturer
Country
United States of America
Address
1500 Park Road, CHANHASSEN, MN, 55317