FDA product code JDN: Implant, Fixation Device, Spinal
JDN is the FDA product code for implant, fixation device, spinal. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under JDN, from 6 different applicants. The average 510(k) review took 144 days (median 144).
Classification
| Field | Value |
|---|---|
| Device name | Implant, Fixation Device, Spinal |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every JDN clearance
Top JDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 1 | 1996-03-08 |
| Stuart | 1 | 1990-06-21 |
| Biedermann Motech GmbH | 1 | 1990-04-25 |
| Roseburg SA | 1 | 1987-12-07 |
| Sofamor Co. | 1 | 1987-12-07 |
1 more applicants have JDN clearances. See the full list in Caduvo.
Most recent JDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954856 | Synthes (Usa) | CANNULATED FEMORAL NAIL | 1996-03-08 | 137 |
| K897141 | Stuart | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | 1990-06-21 | 176 |
| K894184 | Biedermann Motech GmbH | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | 1990-04-25 | 313 |
| K872715 | Roseburg SA | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | 1987-12-07 | 150 |
| K873977 | Sofamor Co. | NEW C-D SYSTEM FOR SPINAL SURGERY | 1987-12-07 | 69 |
Recalls for JDN devices
openFDA lists no recalls for product code JDN.
Frequently asked questions
What is FDA product code JDN?
JDN is the FDA product code for implant, fixation device, spinal. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is JDN?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDN?
Across 6 cleared submissions the average was 144 days from receipt to decision (median 144).
Which companies have the most JDN clearances?
Synthes (Usa) (1); Stuart (1); Biedermann Motech GmbH (1); Roseburg SA (1); Sofamor Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JDN
- Run a recall and safety report across every JDN manufacturer
- Watch product code JDN 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.
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