Summary for ARTG Entry:
LMT Surgical Pty Ltd - MiniFlo External Fixator System - Orthosis, arm, finger
ARTG entry for
Medical Device Included Class IIa
LMT Surgical Pty Ltd
PO Box 41,PADDINGTON, QLD, 4064
ARTG Start Date
Medical Device Class IIa
- 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.
Via Armaroli 21-14
Calderara di Reno, Bologna, 40012
1. MiniFlo External Fixator System - Orthosis, arm, finger
Medical device system
41456 Orthosis, arm, finger
The MiniFlo Fixator is a system comprising a sterile external orthosis (external synthesis device), sterile
instruments, and sterile K-wire. The orthosis (fixator) is an externally applied framework intended to
maintain the position of implanted bone screws (supplied separately) to allow stabilization of finger bones
to promote treatment and healing. The K-wire (Class IIa) is transiently implanted during the surgical
procedure when applying the fixator.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 08:52:00 AEDT
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