Syntellix Granted Approval to Market Devices in India

By Julie A. Vetalice

Syntellix Granted Approval to Market Devices in India

India's Central Drugs Standard Control Organisation granted Syntellix the license to bring five different product families of its bioabsorbable magnesium-based implants to market.

India is ideally suited for collecting further clinical data and conducting clinical trials, and will also contribute significantly to the development of new, additional Syntellix products.

Bioabsorbable MAGNEZIX implants are used for re-establishing bone continuity after fractures, as well as for treating pseudoarthroses. MAGNEZIX implants are metallically stable, similar to systems made of steel or titanium, but unlike screws and wires made of these materials, do not need to be removed again because they are resorbed in the body. MAGNEZIX implants are therefore ideally suitable for fractures that need stable and safe fixation, but where one would rather avoid carrying out another operation after healing to remove the metal.

Source: Syntellix

Product Labels: Trauma Ankle/Foot/Toe

Tags: Regulatory