FDA product code HXW: Bender
HXW is the FDA product code for bender. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under HXW, from 3 different applicants. The average 510(k) review took 39 days (median 20). FDA has posted 3 recalls for HXW devices.
Classification
| Field | Value |
|---|---|
| Device name | Bender |
| 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 HXW clearance
Top HXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buckman Co., Inc. | 1 | 1987-10-15 |
| Military Engineering, Inc. | 1 | 1987-03-09 |
| Terray Manufacturing, Inc. | 1 | 1987-01-28 |
Most recent HXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872949 | Buckman Co., Inc. | ACROMED BONE PLATE BENDER | 1987-10-15 | 79 |
| K870668 | Military Engineering, Inc. | DRIVER-BENDER-EXTRACTOR, BONE PIN | 1987-03-09 | 18 |
| K870084 | Terray Manufacturing, Inc. | RD 140 SURGICAL BENDER | 1987-01-28 | 20 |
Recalls for HXW devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-06-30.
| Year | Recalls |
|---|---|
| 2021 | 2 |
Frequently asked questions
What is FDA product code HXW?
HXW is the FDA product code for bender. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXW?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXW?
Across 3 cleared submissions the average was 39 days from receipt to decision (median 20).
Which companies have the most HXW clearances?
Buckman Co., Inc. (1); Military Engineering, Inc. (1); Terray Manufacturing, Inc. (1).
Have HXW devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2021-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HXW
- Run a recall and safety report across every HXW manufacturer
- Watch product code HXW 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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