JECClass II
Component, Traction, Invasive
21 CFR 888.3040 / Orthopedic
JEC is the FDA product code for Component, Traction, Invasive, a class II device type, regulated under 21 CFR 888.3040. As of , FDA records hold 85 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- JEC
- Device name
- Component, Traction, Invasive
- Regulation
- 21 CFR 888.3040
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 85
- Ingested recalls
- 6
Clearances, product code JEC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 3 |
| 1980 | 5 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 3 |
| 1985 | 2 |
| 1987 | 1 |
| 1988 | 5 |
| 1989 | 2 |
| 1990 | 5 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 6 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 3 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code JEC| Applicant | Clearances |
|---|---|
| Howmedica Corp. | 13 |
| Ace Orthopedic Manufacturing Co. | 5 |
| Hand Biomechanics Lab Inc | 4 |
| Synthes (USA) Products LLC | 4 |
| Acu Med, Inc. | 3 |
| Jerome Medical | 3 |
| Ace Medical | 2 |
| G-5 Florida LLC | 2 |
| Autogenesis, Inc. | 2 |
| Buckman Co., Inc. | 2 |
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.