510(k) K243624

Acu-Sinch Knotless Mini by Acumed, LLC — Product Code HTN

K243624 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "Acu-Sinch Knotless Mini". The FDA issued a decision of Substantially Equivalent on January 23, 2025. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.