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Zdrowie i gospodarka · 25/10/2019

FDA Classifies Orthopedic Surgical Instrumentation for Osteochondral Implants

The FDA has classified orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class II, requiring special controls to ensure safety and effectiveness, aiming to enhance patient access to innovative devices.

Source: Federal Register — Food and Drug AdministrationOpen original release →