FDA product code QHG: Defect Measurement Tool
QHG is the FDA product code for defect measurement tool. It is a Class II device, regulated under 21 CFR 888.4510 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QHG. The average 510(k) review took 27 days (median 27).
Definition
Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
Classification
| Field | Value |
|---|---|
| Device name | Defect Measurement Tool |
| Device class | Class II |
| Regulation | 21 CFR 888.4510 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QHG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 27 |
Compare with all 510(k) review times · Search every QHG clearance
Top QHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intrinsic Therapeutics, Inc. | 1 | 2020-07-16 |
Most recent QHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201676 | Intrinsic Therapeutics, Inc. | Barricaid Instrument Tray | 2020-07-16 | 27 |
Recalls for QHG devices
openFDA lists no recalls for product code QHG.
Frequently asked questions
What is FDA product code QHG?
QHG is the FDA product code for defect measurement tool. It is a Class II device, regulated under 21 CFR 888.4510 and reviewed by the Orthopedic panel.
What device class is QHG?
Class II, regulation 21 CFR 888.4510. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHG?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most QHG clearances?
Intrinsic Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QHG
- Run a recall and safety report across every QHG manufacturer
- Watch product code QHG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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