Surgical procedure kit, orthopaedic, bone cement preparation/delivery
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
Compliance Management Solutions
Class:
Class IIa
Manufactured by:
Tecres SPA Via Andrea Doria 6, Sommacampagna, , Verona, 37066 Italy
Therapeutic area:
45253 - Orthopaedic cement preparation/delivery kit
Therapeutic indications:
The sterile and single-use device is intended for the extrusion of acrylic resins or bone void fillers prepared with a Tecres mixing device, named Shakit. The device is composed of a plastic syringe with luer-lok connection and a scraper ring, a handle, an extrusion screw, and a stainless steel delivery cannula with luer-lok connection.
Authorization status:
A
Authorization date:
2014-02-18
