OXG — Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery Class II

FDA Device Classification

FDA product code OXG covers "Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.

Classification Details

Product Code
OXG
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.