HC Biologics Osteopoint Spinal Fixation System

HC Biologics Osteopoint Spinal Fixation System is an FDA 510(k)-cleared medical device (K250092) manufactured by HC Biologics, 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 March 26, 2025. Regulation: 8.