FDA product code HXP: Instrument, Bending Or Contouring
HXP is the FDA product code for instrument, bending or contouring. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under HXP, from 2 different applicants. The average 510(k) review took 23 days (median 7). FDA has posted 1 recall for HXP devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Bending Or Contouring |
| 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 HXP clearance
Top HXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stainless Mfg., Inc. | 4 | 1980-04-08 |
| Ace Medical Co. | 1 | 1987-10-15 |
Most recent HXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872858 | Ace Medical Co. | WILLIAMS VERTEBRAL SPREADER | 1987-10-15 | 86 |
| K800732 | Stainless Mfg., Inc. | MENISCOTOME | 1980-04-08 | 7 |
| K800730 | Stainless Mfg., Inc. | RETROGRADE KNIFE | 1980-04-08 | 7 |
| K800733 | Stainless Mfg., Inc. | DOUBLE-EDGE CURETTE | 1980-04-08 | 7 |
| K800731 | Stainless Mfg., Inc. | MENISCAL SAW | 1980-04-08 | 7 |
Recalls for HXP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-22.
Frequently asked questions
What is FDA product code HXP?
HXP is the FDA product code for instrument, bending or contouring. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXP?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXP?
Across 5 cleared submissions the average was 23 days from receipt to decision (median 7).
Which companies have the most HXP clearances?
Stainless Mfg., Inc. (4); Ace Medical Co. (1).
Have HXP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code HXP
- Run a recall and safety report across every HXP manufacturer
- Watch product code HXP 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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