Product code HWA— Orthopedic

CEMENT CHISELS

Classification name
Impactor
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
4
First cleared
Most recent

Market context for product code HWA

FDA has cleared 4 devices under product code HWA between 1977 and 1994, filed by 4 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 HWA

Adverse events under product code HWA

product code HWA
Malfunction
12,146
Other
2
Total
12,148

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 HWA

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