DeviceClearance

Product code GXQ— Neurology

Cerafix Dura Substitute

Classification name
Dura Substitute
Device class
Class 2
Regulation
21 CFR 882.5910
Advisory panel
Neurology
Total cleared
43
First cleared
Most recent

Market context for product code GXQ

FDA has cleared 43 devices under product code GXQ between 1995 and 2025, filed by 22 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 GXQ

Adverse events under product code GXQ

product code GXQ
Death
11
Injury
446
Other
1
Total
458

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 GXQ

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