FDA product code HTQ: Broach
HTQ is the FDA product code for broach. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. Devices under HTQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 5 recalls for HTQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Broach |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for HTQ devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code HTQ?
HTQ is the FDA product code for broach. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTQ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
Have HTQ devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2017-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code HTQ
- Run a recall and safety report across every HTQ manufacturer
- Watch product code HTQ 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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