DeviceClearance

Product code OVD— Orthopedic

CHESAPEAKE SPINAL SYSTEM

Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Total cleared
204
First cleared
Most recent

FDA classification definition

“Intended to stabilize lumbar 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 OVD under 21 CFR 888.3080, via openFDA

Market context for product code OVD

FDA has cleared 204 devices under product code OVD between 2007 and 2026, filed by 103 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 OVD

Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

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 OVD

1–100 of 204

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