510(k) K182439

TruShot with Y-Knot Shallow All-Suture Anchor by Conmed Corporation — Product Code MBI

K182439 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "TruShot with Y-Knot Shallow All-Suture Anchor". The FDA issued a decision of Substantially Equivalent on Jan 8, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has 82 other 510(k) clearances on record.