FDA product code HXZ: Cutter, Wire
HXZ is the FDA product code for cutter, wire. 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 HXZ. The average 510(k) review took 43 days (median 43). FDA has posted 1 recall for HXZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cutter, Wire |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Top HXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Military Engineering, Inc. | 1 | 1987-10-28 |
Most recent HXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873715 | Military Engineering, Inc. | BONE PIN CUTTER 18 | 1987-10-28 | 43 |
Recalls for HXZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-11-20.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code HXZ?
HXZ is the FDA product code for cutter, wire. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXZ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXZ?
Across 1 cleared submissions the average was 43 days from receipt to decision (median 43).
Which companies have the most HXZ clearances?
Military Engineering, Inc. (1).
Have HXZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code HXZ
- Run a recall and safety report across every HXZ manufacturer
- Watch product code HXZ 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.