JDQClass II
Cerclage, Fixation
21 CFR 888.3010 / Orthopedic
JDQ is the FDA product code for Cerclage, Fixation, a class II device type, regulated under 21 CFR 888.3010. As of , FDA records hold 130 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- JDQ
- Device name
- Cerclage, Fixation
- Regulation
- 21 CFR 888.3010
- 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
- 130
- Ingested recalls
- 15
Clearances, product code JDQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1988 | 5 |
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 5 |
| 1993 | 7 |
| 1994 | 12 |
| 1995 | 7 |
| 1996 | 7 |
| 1997 | 6 |
| 1998 | 3 |
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 2 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 6 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 6 |
| 2020 | 4 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code JDQ| Applicant | Clearances |
|---|---|
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 13 |
| Howmedica Corp. | 8 |
| Synthes (USA) Products LLC | 8 |
| A & E Medical Corporation | 4 |
| Zimmer GmbH | 4 |
| Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | 4 |
| Spinal Concepts, Inc. | 3 |
| Acu Med, Inc. | 3 |
| Arthrex GmbH | 3 |
| Biodynamic Technologies, Inc. | 3 |
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.