OLC · Class II · 21 CFR 878.3300

FDA Product Code OLC: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen

Intended For Use In Surgical Procedures For The Repair And Reinforcement Of Soft Tissue Injuries Of The Medial Meniscus. In Repairing And Reinforcing Medial Meniscal Defects, The Patient Must Have An Intact Meniscal Rim And Anterior And Posterior Horns For Attachment Of The Mesh. In Addition, The Surgically Prepared Site Must Extend At Least Into The Red/white Zone Of The Meniscus To Provide Sufficient Vascularization. The Device Reinforces Soft Tissue And Provides A Resorbable Scaffold That Is Replaced By The Patients Own Soft Tissue. The Device Is Not A Prosthetic Device And Is Not Intended To Replace Normal Body Structure.

Leading manufacturers include Collagen Matrix, Inc..

1
Total
1
Cleared
58d
Avg days
2024
Since

List of Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen 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 Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen devices (product code OLC). 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 →