QGQ — Bone Indentation Device Class II

FDA Device Classification

FDA product code QGQ covers "Bone Indentation Device", a Class II medical device regulated under 21 CFR 888.1600. Submissions are reviewed by the Orthopedic panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
QGQ
Device Class
Class II
Regulation Number
888.1600
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250216active life scientificOsteoProbe (OP-100)September 11, 2025
K221195active life scientificOsteoProbeJune 28, 2022
DEN210013active life scientificOsteoProbeAugust 19, 2021