Spacer-G Flat Stem - Cement, orthopaedic, bone spacer
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-10-2022
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Available from:
Compliance Management Solutions
Class:
Class III
Manufactured by:
Tecres SPA Via Andrea Doria 6, Sommacampagna, , Verona, 37066 Italy
Therapeutic area:
33982 - Cement, orthopaedic, bone spacer
Therapeutic indications:
A device temporarily placed into the hip joint space to prevent bone on bone contact and contraction of soft tissue during the treatment of an infected joint. The device locally releases gentamicin to help the treatment of the infection. The Spacer-G Flat Stem comes in 6 sizes. Spacer-G Flat Stem is indicated for temporary use (maximum 180 days) in total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
Authorization status:
A
Authorization date:
2022-04-20
