FDA product code HXN: Applier, Cerclage
HXN is the FDA product code for applier, cerclage. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under HXN, from 2 different applicants. The average 510(k) review took 72 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Applier, Cerclage |
| 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 HXN clearance
Top HXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 1 | 2003-01-23 |
| Plastafil, Inc. | 1 | 1984-07-23 |
Most recent HXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K024022 | Biomet, Inc. | OSTEO-CABLE SLEEVE | 2003-01-23 | 49 |
| K841628 | Plastafil, Inc. | WIRE | 1984-07-23 | 95 |
Recalls for HXN devices
openFDA lists no recalls for product code HXN.
Frequently asked questions
What is FDA product code HXN?
HXN is the FDA product code for applier, cerclage. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXN?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXN?
Across 2 cleared submissions the average was 72 days from receipt to decision (median 72).
Which companies have the most HXN clearances?
Biomet, Inc. (1); Plastafil, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HXN
- Run a recall and safety report across every HXN manufacturer
- Watch product code HXN 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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