DZK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wire, Fixation, Intraosseous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4880
- Medical specialty
- Dental
- Flags
- Implant
- Adverse events (MAUDE)
- 2006: 4 · 2007: 2 · 2008: 2 · 2012: 9 · 2013: 6 · 2015: 7
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 |
|---|---|---|
| SPRYTIE, MODELS ST001, ST002 AND ST003 (K092530) | Russell B. Walther | 2010-04-02 |
| ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E (K022821) | Ideatrics, Inc. | 2002-11-15 |
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Every clearance here is in the API, with alerts when new ones post.