FDA Product Code OWX: Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon
For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.
Leading manufacturers include Anika Therapeutics, Inc., ZuriMED Technologies AG and Arthrex, Inc..
FDA 510(k) Cleared Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon Devices (Product Code OWX)
About Product Code OWX - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code OWX since 2023, with 5 receiving FDA clearance (average review time: 160 days).
Submission volume has increased in recent years - 4 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 OWX have taken an average of 133 days to reach a decision - down from 267 days historically, suggesting improved FDA processing for this classification.
OWX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →