FDA product code HXO: Pusher, Socket
HXO is the FDA product code for pusher, socket. 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 HXO, from 3 different applicants. The average 510(k) review took 24 days (median 16). FDA has posted 1 recall for HXO devices.
Classification
| Field | Value |
|---|---|
| Device name | Pusher, Socket |
| 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 HXO clearance
Top HXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cobot Medical Corp. | 1 | 1989-02-08 |
| Zimmer, Inc. | 1 | 1980-12-31 |
| Depuy, Inc. | 1 | 1977-06-27 |
Most recent HXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K885305 | Cobot Medical Corp. | ACETABULAR CUP PUSHER/IMPACTOR | 1989-02-08 | 43 |
| K803165 | Zimmer, Inc. | ACETABULAR CEMENT COMPRESSOR | 1980-12-31 | 16 |
| K771072 | Depuy, Inc. | INSERTEO, META.-PHAL.&THUMB CARPO-META | 1977-06-27 | 13 |
Recalls for HXO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-08-02.
Frequently asked questions
What is FDA product code HXO?
HXO is the FDA product code for pusher, socket. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXO?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXO?
Across 3 cleared submissions the average was 24 days from receipt to decision (median 16).
Which companies have the most HXO clearances?
Cobot Medical Corp. (1); Zimmer, Inc. (1); Depuy, Inc. (1).
Have HXO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code HXO
- Run a recall and safety report across every HXO manufacturer
- Watch product code HXO 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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