FDA Product Code OXF: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
Leading manufacturers include Printbio, Inc. and Acera Surgical, Inc..
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery Devices (Product Code OXF)
About Product Code OXF - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code OXF since 2013, with 8 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OXF have taken an average of 181 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
OXF devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →