21 CFR § 878.3300 General and Plastic Surgery Devices

§ 878.3300 Surgical mesh.

Current through Sep 8, 2026 · Read all of Part 878

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.

← § 878.3250 External facial fracture fixation appliance.§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material. →