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ConforMIS Granted FDA 510(k) Clearance for Knee Replacement System; Shares Surge 25% Pre-Bell

05/10/2021 05:06

08:58 AM EDT, 05/10/2021 (MT Newswires) -- ConforMIS (CFMS) reported that it has received 510(k) clearance by the US Food and Drug Administration for the medical technology company's Identity Imprint Knee Replacement System.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA that they intend to market a medical device at least 90 days in advance to allow the FDA to determine whether the device is equivalent to one that has already been approved.

Shares of ConforMIS are up nearly 25% in premarket trading.

Price: 1.0500, Change: +0.21, Percent Change: +24.78