IOZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Splint, Abduction, Congenital Hip Dislocation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3665
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1996: 1 · 2002: 2
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 |
|---|---|---|
| ABDUCTION PILLOW (K830243) | Warm & Form, Orthopedic Materials | 1983-03-08 |
| ABDUCTION PILLOW (K823820) | Danek Medical, Inc. | 1983-01-14 |
| HIP ABDUCTION SPLINT (K810557) | Orthomedics | 1981-03-13 |
| PAVLIK HARNESS (K780375) | Biomet, Inc. | 1978-03-15 |
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Every clearance here is in the API, with alerts when new ones post.