DeviceClearance

Product code OXF— General, Plastic Surgery

3DMatrix DynaFlex (DynaFlex)

Classification name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
8
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OXF under 21 CFR 878.3300, via openFDA

Market context for product code OXF

FDA has cleared 8 devices under product code OXF between 2013 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OXF

Recent clearances under product code OXF

Data sourced from openFDA. This site is unofficial and independent of the FDA.