QGQ · Class II · 21 CFR 888.1600

FDA Product Code QGQ: Bone Indentation Device

A Bone Indentation Device Is A Device That Measures Resistance To Indentation In Bone.

Leading manufacturers include Active Life Scientific, Inc..

3
Total
2
Cleared
145d
Avg days
2021
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 230d recently vs 103d historically

FDA 510(k) Cleared Bone Indentation Device Devices (Product Code QGQ)

3 devices
1–3 of 3

About Product Code QGQ - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QGQ since 2021, with 2 receiving FDA clearance (average review time: 145 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under QGQ have taken an average of 230 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.

QGQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →