OWX · Class II · 21 CFR 878.3300

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 Arthrex, Inc..

1
Total
1
Cleared
202d
Avg days
2025
Since

List of Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon devices (product code OWX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →