DeviceClearance

Product code HTJ— Orthopedic

ACROMED INTERBODY DEPTH GAUGES

Classification name
Gauge, Depth
Device class
Class 1
Regulation
21 CFR 888.4300
Advisory panel
Orthopedic
Total cleared
4
First cleared
Most recent

Market context for product code HTJ

FDA has cleared 4 devices under product code HTJ between 1986 and 1994, 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 HTJ

Adverse events under product code HTJ

product code HTJ
Malfunction
2,320
Total
2,320

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 HTJ

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