HAXClass II
Tong, Skull For Traction
21 CFR 882.5960 / Neurology
HAX is the FDA product code for Tong, Skull For Traction, a class II device type, regulated under 21 CFR 882.5960. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 13 recalls.
Classification record
- Product code
- HAX
- Device name
- Tong, Skull For Traction
- Regulation
- 21 CFR 882.5960
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 20
- Ingested recalls
- 13
Clearances, product code HAX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1999 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2009 | 1 |
Applicants with the most clearances
Product code HAX| Applicant | Clearances |
|---|---|
| Jerome Medical | 2 |
| Progress Mankind Technology | 2 |
| Ace Medical | 1 |
| Ace Orthopedic Manufacturing Co. | 1 |
| American Threshold Industries, Inc. | 1 |
| Applied Medical Systems | 1 |
| Bremer Medical, Inc. | 1 |
| Bremer Orthopedics | 1 |
| Buckman Co., Inc. | 1 |
| Cerenovus, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
