DeviceClearance

Product code ODP— Orthopedic

Reliance Cervical IBF System

Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Total cleared
354
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.”

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

Market context for product code ODP

FDA has cleared 354 devices under product code ODP between 2008 and 2026, filed by 205 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 ODP

Adverse events under product code ODP

product code ODP
Injury
310
Total
310

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 ODP

1–100 of 354

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