Product code HWX— Orthopedic

ACROMED BONE SCREW TAP SLEEVES

Classification name
Tap, Bone
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

Market context for product code HWX

FDA has cleared 2 devices under product code HWX between 1984 and 1987, filed by 2 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 HWX

Adverse events under product code HWX

product code HWX
Malfunction
559
Total
559

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 HWX

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