510(k) K182446

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

K182446 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "TruShot with Y-Knot All-Suture Anchor". The FDA issued a decision of Substantially Equivalent on Dec 19, 2018. 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.