FDA Product Code QUW: Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair.
Leading manufacturers include Xiros, Ltd., Xiros Limited and Theramicro.
FDA 510(k) Cleared Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament Devices (Product Code QUW)
About Product Code QUW - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QUW since 2022, with 3 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 2 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 QUW have taken an average of 203 days to reach a decision - up from 90 days historically. Manufacturers should account for longer review timelines in current project planning.
QUW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →