510(k) K231493

NITINEX Memory Compression Staple by Vilex, LLC — Product Code JDR

K231493 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "NITINEX Memory Compression Staple". The FDA issued a decision of Substantially Equivalent on August 11, 2023. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Vilex, LLC has at least 10 other 510(k) clearances on record.