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§ 878.3300 Surgical mesh.

21 CFR 878.3300

Citation21 CFR 878.3300
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 878.3300 Surgical mesh.

(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.