QNI · Class II · 21 CFR 888.3044

FDA Product Code QNI: Resorbable Implant For Anterior Cruciate Ligament (acl) Repair

A Resorbable Implant For Anterior Cruciate Ligament (acl) Repair Is A Degradable Material That Allows For Healing Of A Torn Acl That Is Biomechanically Stabilized By Traditional Suturing Procedures. The Device Is Intended To Protect The Biological Healing Process From The Surrounding Intraarticular Environment And Not Intended To Replace Biomechanical Fixation Via Suturing. This Classification Includes Devices That Bridge Or Surround The Torn Ends Of A Ruptured Acl.

Leading manufacturers include Miach Orthopaedics, Inc..

1
Total
1
Cleared
270d
Avg days
2026
Since

FDA 510(k) Cleared Resorbable Implant For Anterior Cruciate Ligament (acl) Repair Devices (Product Code QNI)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Resorbable Implant For Anterior Cruciate Ligament (acl) Repair devices (product code QNI). 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 →