21 CFR § 878.3300 - Surgical mesh.

---
identifier: "/us/cfr/t21/s878.3300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.3300 - Surgical mesh."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.3300"
section_name: "Surgical mesh."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 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.