DeviceClearance

Product code OVE— Orthopedic

E3D-C Interbody System

Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Total cleared
166
First cleared
Most recent

FDA classification definition

“Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.”

— U.S. Food and Drug Administration, device classification record for product code OVE under 21 CFR 888.3080, via openFDA

Market context for product code OVE

FDA has cleared 166 devices under product code OVE between 2007 and 2026, filed by 99 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

last 15 years

Top applicants under product code OVE

Adverse events under product code OVE

product code OVE
Injury
293
Malfunction
710
Total
1,003

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OVE

1–100 of 166

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