DeviceClearance

Product code HXC— Orthopedic

ADJUSTABLE WRENCHES

Classification name
Wrench
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
6
First cleared
Most recent

Market context for product code HXC

FDA has cleared 6 devices under product code HXC between 1979 and 2018, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code HXC

Adverse events under product code HXC

product code HXC
Malfunction
851
Total
851

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 HXC

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