510(k) K193402

ALLthread PEEK Suture Anchor by Biomet, Inc. — Product Code MBI

K193402 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "ALLthread PEEK Suture Anchor". The FDA issued a decision of Substantially Equivalent on March 5, 2020. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet, Inc. has at least 10 other 510(k) clearances on record.