510(k) K163672

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor by Nanova Biomaterials, Inc. — Product Code MAI

K163672 is an FDA 510(k) premarket notification submitted by Nanova Biomaterials, Inc. for the device "Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor". The FDA issued a decision of Substantially Equivalent on May 5, 2017. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Nanova Biomaterials, Inc. has at least 7 other 510(k) clearances on record.