Bone Indentation Device
The Bone Indentation Device is an orthopedic measurement device that assesses bone quality and strength by measuring resistance to indentation in bone, providing intraoperative or clinical information about bone mechanical properties. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 888.1600 in the Orthopedic specialty. The product code is QGQ. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGQ
- Device Class
- FDA class 2
- Regulation Number
- 888.1600
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
A bone indentation device is a device that measures resistance to indentation in bone.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250216 | OsteoProbe (OP-100) | Sep 11, 2025 | Substantially Equivalent | Active Life Scientific, Inc. |
| K221195 | OsteoProbe | Jun 28, 2022 | Substantially Equivalent | Active Life Scientific, Inc. |
| DEN210013 | OsteoProbe | Aug 19, 2021 | Unknown | Active Life Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.