IQF
7 FDA 510(k) clearances · Product code
16 daysmedian time to decision
36 days90th percentile
7clearances measured
FDA profile
- Official device name
- Orthosis, Cervical-Thoracic, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1998: 1 · 2008: 3
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 |
|---|---|---|
| JASON CERVICAL ORTHOSIS (K832741) | Orthomedics | 1983-09-20 |
| ZEE EXTRICATION DEVICE (K812342) | Zee Medical Products Co., Inc. | 1981-09-21 |
| CERVICAL SUPPORT (K811297) | Orthomedics | 1981-05-27 |
| SCOLIOSIS ORTHOTIC SYSTEM (K810555) | Orthomedics | 1981-03-13 |
| POPE AMBULATORY HALO VEST (K791350) | Hospital Products Co. | 1979-08-03 |
| KENDRICK EXTRICATION DEVICE (K781761) | Medi-Ked, Inc. | 1978-10-27 |
| SPINE BOARD (K780489) | Marullo, Baldwin, Frieden, Gatewood, | 1978-04-12 |
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Every clearance here is in the API, with alerts when new ones post.