OSN · Class II · 21 CFR 888.3030

FDA Product Code OSN: Software For Diagnosis/treatment

Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions

Leading manufacturers include Smith & Nephew, Inc..

1
Total
1
Cleared
65d
Avg days
2022
Since

List of Software For Diagnosis/treatment devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Aug 25, 2022
Acute QC Strut and Components
K221792
Smith & Nephew, Inc.
Orthopedic · 65d

How to use this database

This page lists all FDA 510(k) submissions for Software For Diagnosis/treatment devices (product code OSN). 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 →