Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
ACRA Regulatory Services Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile
ARTG entry for
Medical Device Included Class IIb
ACRA Regulatory Services Pty Ltd
7/84 Poincina Avenue,Tewantin, QLD, 4565
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.
83 South Commerce Way Suite 310
Bethlehem, Pennsylvania, 18017
United States Of America
1. Orthopaedic bone screw, non-biodegradable, non-sterile
Single Device Product
56642 Orthopaedic bone screw, non-biodegradable, non-sterile
Trauma screw designed to apply compression and fixation between two adjacent segments of cortical
and/or cancellous bone and intended to be for use in bone reconstruction, osteotomy, arthrodesis, joint
fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are
intended for single use only.
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Produced at 02.11.2019 at 03:31:09 AEDT
This is not an ARTG Certificate document.
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