JDN
6 FDA 510(k) clearances · Product code
150 daysmedian time to decision
313 days90th percentile
6clearances measured
FDA profile
- Official device name
- Implant, Fixation Device, Spinal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2010: 5 · 2012: 8 · 2013: 64 · 2014: 17 · 2015: 23 · 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CANNULATED FEMORAL NAIL (K954856) | Synthes (Usa) | 1996-03-08 |
| SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (K897141) | Stuart | 1990-06-21 |
| BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM (K894184) | Biedermann Motech GmbH | 1990-04-25 |
| UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (K872715) | Roseburg SA | 1987-12-07 |
| NEW C-D SYSTEM FOR SPINAL SURGERY (K873977) | Sofamor Co. | 1987-12-07 |
| TOTAL SPINAL CORRECTION (K760649) | Depuy, Inc. | 1976-10-05 |
Track JDN automatically
Every clearance here is in the API, with alerts when new ones post.