Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)

Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) is an FDA 510(k)-cleared medical device (K200290) manufactured by SeaSpine Orthopedics Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 2020. Regulation: 8.