Shalby receives USFDA clearance for knee replacement device
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-21 04:30 GMT | Update On 2025-01-21 04:30 GMT
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Shalby Advanced Technologies Inc., USA, a step down subsidiary of the Company has received U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Clearance for DuraniomTM, our Primary Total Knee Replacement device with TiNbN coating, on January 14, 2025.
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Based on the safety and effectiveness data, FDA has determined the device is substantially equivalent to legally marketed predicate devices.
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