FDA product code HXS: Twister, Wire
HXS is the FDA product code for twister, wire. 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 HXS, from 2 different applicants. The average 510(k) review took 47 days (median 47). FDA has posted 2 recalls for HXS devices.
Classification
| Field | Value |
|---|---|
| Device name | Twister, Wire |
| 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 HXS clearance
Top HXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bionic Instrument Corp. | 1 | 1983-12-22 |
| Orthopedic Equipment Co., Inc. | 1 | 1978-09-27 |
Most recent HXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833726 | Bionic Instrument Corp. | KLEIN WIRE TIGHTENER/BIONIC WIRE | 1983-12-22 | 59 |
| K781451 | Orthopedic Equipment Co., Inc. | FLAT WRENCH | 1978-09-27 | 35 |
Recalls for HXS devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-28.
Frequently asked questions
What is FDA product code HXS?
HXS is the FDA product code for twister, wire. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXS?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXS?
Across 2 cleared submissions the average was 47 days from receipt to decision (median 47).
Which companies have the most HXS clearances?
Bionic Instrument Corp. (1); Orthopedic Equipment Co., Inc. (1).
Have HXS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-08-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HXS
- Run a recall and safety report across every HXS manufacturer
- Watch product code HXS 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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