Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Acumed, LLC
Free shipping on orders over $99 · 30-day returns
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR is an FDA 510(k)-cleared medical device (K112111) manufactured by Acumed, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2011. Regulation: 8.