21 C.F.R. § 878.3300   Surgical mesh.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart D—Prosthetic Devices

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§ 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.

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