Summary for ARTG Entry:
Prism Surgical Designs Pty Ltd - Spinal fixation plate, non-biodegradable
ARTG entry for
Medical Device Included Class IIb
Prism Surgical Designs Pty Ltd
PO Box 27,RED HILL, QLD, 4059
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.
Signature Orthopaedics Europe Ltd
14 Herbert Street Dublin 2
1. Spinal fixation plate, non-biodegradable
Single Device Product
46653 Spinal fixation plate, non-biodegradable
This device is attached to the anterior/posterior spine with screws for spinal immobilization. It is typically
used to provide immobilization and stabilization of the spinal segments in the treatment of various spinal
instabilities or deformities during cervical, thoracic, lumbar and sacral fixation procedures.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:33:40 AEDT
This is not an ARTG Certificate document.
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