OXF

Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Product code
OXF
Device name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
8

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-06-20.

NumberDecision dateApplicantDevice nameSummary
K2512242025-06-20Acera Surgical, Inc.Restrata Soft Tissue Reinforcement (STR)PDF
K2433022025-05-21Printbio, Inc.3DMatrix DynaFlex (DynaFlex)PDF
K2326022024-05-23Printbio, Inc.3DMatrix Surgical MeshPDF

3 summaries are archived here for direct download.

Official FDA classification page: OXF
Classification and pathway per current FDA publications. Data from openFDA (CC0).