Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is an FDA 510(k)-cleared medical device (K182705) manufactured by B-One Ortho, Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2019. Regulation: 8.