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
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
230d
recently vs 103d historically
FDA 510(k) Cleared Bone Indentation Device Devices (Product Code QGQ)
3 devices
Cleared
Sep 11, 2025
OsteoProbe (OP-100)
Active Life Scientific, Inc.
Orthopedic
230d
Cleared
Jun 28, 2022
OsteoProbe
Active Life Scientific, Inc.
Orthopedic
64d
Not Cleared
Aug 19, 2021
OsteoProbe
Active Life Scientific, Inc.
Orthopedic
142d
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QGQ Product Code
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 →