Device Dossier

Surgical instrument torque limiter

Device Dossier for Surgical instrument torque limiter (Surgical instrument torque limiter, Class IIa, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The Torque limiting attachment for speed reduction (TLA) is a sterile single-use (single-procedure) surgical instrument intended for the final-tightening of medical fasteners. The TLA is designed for use with a compatible surgical handpiece, provides speed reduction and which limits torque when installing screws during a surgical procedure. This device is not intended for revision procedures nor to loosen medical fasteners.

TGA Public Summary