
Core Essence Orthopaedics, LLC
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RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X is an FDA 510(k)-cleared medical device (K071520) manufactured by Core Essence Orthopaedics, 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 August 9, 2007. Regulation: 8.