Product code HWR— Orthopedic

ACROMED ADS BONE NAIL DRIVER

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

Market context for product code HWR

FDA has cleared 4 devices under product code HWR between 1987 and 1992, filed by 3 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 HWR

Adverse events under product code HWR

product code HWR
Malfunction
6,549
Total
6,549

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 HWR

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