FDA product code HAX: Tong, Skull For Traction
HAX is the FDA product code for tong, skull for traction. It is a Class II device, regulated under 21 CFR 882.5960 and reviewed by the Neurology panel. FDA has cleared 20 510(k) submissions under HAX, from 18 different applicants. The average 510(k) review took 155 days (median 56). FDA has posted 13 recalls for HAX devices.
Classification
| Field | Value |
|---|---|
| Device name | Tong, Skull For Traction |
| Device class | Class II |
| Regulation | 21 CFR 882.5960 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HAX clearance
Top HAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jerome Medical | 2 | 2005-08-17 |
| Progress Mankind Technology | 2 | 1987-06-19 |
| Pmt Corp. | 1 | 2009-07-28 |
| Ossur Americans (Formerly the Jerome Group) | 1 | 2007-05-25 |
| The Jerome Group, Inc. | 1 | 2003-02-21 |
13 more applicants have HAX clearances. See the full list in Caduvo.
Most recent HAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090733 | Pmt Corp. | PMT HALO SYSTEM | 2009-07-28 | 131 |
| K071173 | Ossur Americans (Formerly the Jerome Group) | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | 2007-05-25 | 28 |
| K051918 | Jerome Medical | RESOLVE OPEN BACK HALO RINGS | 2005-08-17 | 33 |
| K023959 | The Jerome Group, Inc. | JEROME GLASS RING | 2003-02-21 | 86 |
| K003662 | Spine Works | SPINE WORKS COLLAR | 2001-07-09 | 223 |
Recalls for HAX devices
13 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-21.
| Year | Recalls |
|---|---|
| 2018 | 4 |
Frequently asked questions
What is FDA product code HAX?
HAX is the FDA product code for tong, skull for traction. It is a Class II device, regulated under 21 CFR 882.5960 and reviewed by the Neurology panel.
What device class is HAX?
Class II, regulation 21 CFR 882.5960. Typical premarket route: 510(k).
How long does a 510(k) take for product code HAX?
Across 20 cleared submissions the average was 155 days from receipt to decision (median 56).
Which companies have the most HAX clearances?
Jerome Medical (2); Progress Mankind Technology (2); Pmt Corp. (1); Ossur Americans (Formerly the Jerome Group) (1); The Jerome Group, Inc. (1).
Have HAX devices been recalled?
Yes: 13 product recalls across 3 recall events; the most recent began 2018-06-21.
Next steps
- Run an FDA pathway report with predicate devices for product code HAX
- Run a recall and safety report across every HAX manufacturer
- Watch product code HAX 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times