510(k) K223114

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors by Gm Dos Reis Industria E Comerico Ltda. — Product Code MBI

K223114 is an FDA 510(k) premarket notification submitted by Gm Dos Reis Industria E Comerico Ltda. for the device "Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors". The FDA issued a decision of Substantially Equivalent on August 2, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Gm Dos Reis Industria E Comerico Ltda. has at least 2 other 510(k) clearances on record.