510(k) K240947

TENSOR® Suture Button System by Globus Medical, Inc. — Product Code HTN

K240947 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "TENSOR® Suture Button System". The FDA issued a decision of Substantially Equivalent on June 3, 2024. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.