BIO-INTRAFIX Tibial Sheath - Prosthesis, internal, ligament, anchor
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
02-12-2017
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Available from:
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Class:
Class III
Manufactured by:
Depuy Mitek (a Johnson & Johnson Company) 325 Paramount Drive, Raynham, MA, 02767 United States Of America
Therapeutic area:
36174 - Ligament anchor
Therapeutic indications:
An absorbable tibial sheath made from a composite of Polylactic Acid Polymer (PLA) and Tricalcium Phosphate (TCP) used with the BIO-INTRAFIX tibial tapered screw to secure soft tissue grafts to the bone in cruciate ligament reconstruction. For fixation of soft tissue grafts to the bone in cruciate ligament reconstruction
Authorization status:
A
Authorization date:
2007-03-20
