JDOClass II
Device, Fixation, Proximal Femoral, Implant
21 CFR 888.3030 / Orthopedic
JDO is the FDA product code for Device, Fixation, Proximal Femoral, Implant, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- JDO
- Device name
- Device, Fixation, Proximal Femoral, Implant
- Regulation
- 21 CFR 888.3030
- 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
- 23
- Ingested recalls
- 8
Clearances, product code JDO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1981 | 1 |
| 1983 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2008 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code JDO| Applicant | Clearances |
|---|---|
| Smith & Nephew, Inc. | 5 |
| Synthes (USA) Products LLC | 5 |
| Zimmer GmbH | 4 |
| Globus Medical, Inc. | 2 |
| Biomet Manufacturing Corp | 1 |
| Deutschland Surgical, Inc. | 1 |
| Efratgo, Ltd. HI Tech Bio-Surgical | 1 |
| Howmedica Corp. | 1 |
| Kirschner Medical Corp. | 1 |
| OsteoCentric Technologies,Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- ARCH Medical Solutions - Memphis
- Arvato USA LLC
- B & G Mfg. Co.
- BBF Sterilisationsservice GmbH
- Biomet Global Supply Chain Center B.V.
- Complexus Medical
- DePuy Synthes Sales
- Engineered Medical Systems, LLC
- Exel Inc. dba DHL Supply Chain (USA)
- Ferry Machine Corporation
- Flex-Cell Precision, Inc.
- Gauthier Biomedical, Inc.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
