Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ is an FDA 510(k)-cleared medical device (K234013) manufactured by Bone Solutions, Inc.. 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 4, 2024. Regulation: 8.