FDA product code HXG: Tamp
HXG is the FDA product code for tamp. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under HXG. The average 510(k) review took 130 days (median 130).
Classification
| Field | Value |
|---|---|
| Device name | Tamp |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXG clearance
Top HXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plastafil, Inc. | 1 | 1984-08-27 |
Most recent HXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841626 | Plastafil, Inc. | PUNCH | 1984-08-27 | 130 |
Recalls for HXG devices
openFDA lists no recalls for product code HXG.
Frequently asked questions
What is FDA product code HXG?
HXG is the FDA product code for tamp. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXG?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXG?
Across 1 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most HXG clearances?
Plastafil, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HXG
- Run a recall and safety report across every HXG manufacturer
- Watch product code HXG 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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