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Shalby’s step down arm receives USFDA’s approval for Duraniom

16 Jan 2025 Evaluate

Shalby’s step down subsidiary -- Shalby Advanced Technologies (SAT) Inc., USA, has received U.S. Food and Drug Administration (USFDA) 510(k) Premarket Notification Clearance for Duraniom, its Primary Total Knee Replacement device with TiNbN coating, on January 14, 2025. Based on the safety and effectiveness data, USFDA has determined the device is substantially equivalent to legally marketed predicate devices. 

Shalby is one of the leading multi-specialty chains of hospitals in India.


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