Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (OWW) (2) Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (OWY) (2)