DeviceClearance

Product code QGQ— Orthopedic

OsteoProbe

Classification name
Bone Indentation Device
Device class
Class 2
Regulation
21 CFR 888.1600
Advisory panel
Orthopedic
Total cleared
3
First cleared
Most recent

FDA classification definition

“A bone indentation device is a device that measures resistance to indentation in bone.”

— U.S. Food and Drug Administration, device classification record for product code QGQ under 21 CFR 888.1600, via openFDA

Market context for product code QGQ

FDA has cleared 3 devices under product code QGQ between 2021 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QGQ

Recent clearances under product code QGQ

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