Morpheus® Moldable; Agilon® Moldable

Morpheus® Moldable; Agilon® Moldable is an FDA 510(k)-cleared medical device (K240621) manufactured by Biogennix, 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 April 29, 2024. Regulation: 8.