Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Fixation device, internal, wire
ARTG entry for
Medical Device Included Class IIb
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Paragon 28 Inc
4B Inverness Ct East Suite 280
Englewood, Colorado, 80112
United States Of America
1. Fixation device, internal, wire
Single Device Product
35685 Fixation device, internal, wire
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in
bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the
joint. Additionally, they are indicated as guide pins for insertion of instruments and implants.
No Specific Conditions included on Record
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Produced at 01.12.2017 at 11:45:40 AEDT
This is not an ARTG Certificate document.
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