Surgical instrument torque-limiting handle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

RTI Surgical Australia Pty Ltd

Class:

Class I

Manufactured by:

Pioneer Surgical Technology Inc 375 River Park Circle, MARQUETTE, MICHIGAN, 49855 United States Of America

Therapeutic area:

47830 - Surgical instrument torque-limiting handle

Therapeutic indications:

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw (e.g., the insertion of pedicle screws), whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The handle provides an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Authorization status:

A

Authorization date:

2012-05-17