DeviceClearance

Product code ONN— Neurology

ELIBRA DYNAMIC KNEE BALANCER

Classification name
Intraoperative Orthopedic Joint Assessment Aid
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
18
First cleared
Most recent

FDA classification definition

“Measurement and interpretation of orthopedic joint information.”

— U.S. Food and Drug Administration, device classification record for product code ONN under 21 CFR 882.4560, via openFDA

Market context for product code ONN

FDA has cleared 18 devices under product code ONN between 2007 and 2026, filed by 7 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 ONN

Recent clearances under product code ONN

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