OWY · Class II · 21 CFR 878.3300

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 Arthrex, Inc..

1
Total
1
Cleared
120d
Avg days
2025
Since

List of Mesh, Surgical, Collagen, 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, Collagen, Orthopaedics, Reinforcement Of Tendon devices (product code OWY). 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 →