FDA Product Code OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.
Leading manufacturers include Smith and Nephew, Inc., Smith & Nephew Inc., Endoscopy Div. and Kerecis Limited.
FDA 510(k) Cleared Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon Devices (Product Code OWY)
About Product Code OWY - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code OWY since 2012, with 14 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OWY have taken an average of 109 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
OWY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →