Shalby Arm Gets US FDA Nod for Knee Replacement Device

MT Newswires Live

01/16

Shalby Advanced Technologies (SAT), USA, a step-down subsidiary of Shalby (NSE:SHALBY, BOM:540797) has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.

The company received "premarket notification clearance" for the total knee replacement device with TiNbN coating.

Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.

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