Summary for ARTG Entry:
Tornier Pty Ltd - InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable
ARTG entry for
Medical Device Included Class III
Tornier Pty Ltd
PO Box 230,BELROSE, NSW, 2085
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.
10801 Nesbitt Avenue South
Bloomington, MN, 55437
United States Of America
1. InsiteTM FT Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable
Single Device Product
45061 Fixation anchor, soft-tissue, biodegradable
'The Tornier InsiteTM FT Biocomposite Suture Anchor is a composite (PLLA/TCP) absorbable fully
threaded suture anchor preloaded on a disposable inserter assembly with two or three strands of braided
UHMWPE non-absorbable size #2 suture available with or without needles'
Intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow repairs
Diameter (mm) 4.5 - 6.5
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:21:56 AEDT
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