510(k) K210239

CITRESPLINE and CITRELOCK ACL Implants by Acuitive Technologies, Inc. — Product Code MAI

K210239 is an FDA 510(k) premarket notification submitted by Acuitive Technologies, Inc. for the device "CITRESPLINE and CITRELOCK ACL Implants". The FDA issued a decision of Substantially Equivalent on February 24, 2021. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Acuitive Technologies, Inc. has at least 6 other 510(k) clearances on record.