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,…
- GMDN category: Surgical instrument torque limiter
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.