Summary for ARTG Entry:
Scientx Australia - Samarys RF - Spinal cage
ARTG entry for
Medical Device Included Class III
1/575 Darling Street,ROZELLE, NSW, 2039
ARTG Start Date
Medical Device Class III
- 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.
18 chemin de la Violette
L'union, , 31240
1. Samarys RF - Spinal cage
Single Device Product
38161 Spinal cage
SAMARYS RF is a cervical cage, pre-filled with a synthetic bone substitute and pre-loaded on a
disposable cage inserter ancillary. The pre-filled cervical cage is designed to be implanted into
intervertebral spaces when performing intersomatic cervical arthrodesis. When the assembly is delivered,
the stainless steel insertion ancillary is already screwed onto the prefilled cage. This facilitates the surgical
procedure and also makes it possible to insert a pre-filled cage.
The Samarys RF is intended for use in anterior approach cervical fusion, in order to optimize bone fusion
at levels C3 to C7. It is indicated for:
- stabilization after curettage in the event of cervical disc herniation or compressive osteophytosis affecting
the nerve roots and/or the spinal cord
- degenerative intervertebral instability
The implant (cage + bone substitute) is useful, in particular,to achieve radicular decompression by
Length (mm) 12 to 15 (also known as depth)
Width (mm) 15-20
Height (mm) 4.5 to 10
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:22:52 AEDT
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