Screwdriver, surgical

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Alphatec Australia Pty Ltd

Class:

Class I

Manufactured by:

TeDan Surgical Innovations Inc 12320 Cardinal Meadow Drive Suite 150, Sugar Land, TX, 77478 United States Of America

Therapeutic area:

33968 - Screwdriver, surgical

Therapeutic indications:

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Authorization status:

A

Authorization date:

2022-12-20