DeviceClearance

Product code MAX— Orthopedic

FlareHawk Interbody Fusion System

Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Total cleared
896
First cleared
Most recent

FDA classification definition

“Intended to stabilize 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 MAX under 21 CFR 888.3080, via openFDA

Market context for product code MAX

FDA has cleared 896 devices under product code MAX between 2007 and 2026, filed by 294 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 MAX

Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

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 MAX

1–100 of 896

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