DeviceClearance

Product code OSN— Orthopedic

Acute QC Strut and Components

Classification name
Software For Diagnosis/Treatment
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
4
First cleared
Most recent

FDA classification definition

“Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions”

— U.S. Food and Drug Administration, device classification record for product code OSN under 21 CFR 888.3030, via openFDA

Market context for product code OSN

FDA has cleared 4 devices under product code OSN between 2014 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OSN

Recent clearances under product code OSN

Data sourced from openFDA. This site is unofficial and independent of the FDA.