FDA product code IOZ: Splint, Abduction, Congenital Hip Dislocation
IOZ is the FDA product code for splint, abduction, congenital hip dislocation. It is a Class I device, regulated under 21 CFR 890.3665 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under IOZ, from 4 different applicants. The average 510(k) review took 22 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Abduction, Congenital Hip Dislocation |
| Device class | Class I |
| Regulation | 21 CFR 890.3665 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IOZ clearance
Top IOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 1 | 1983-03-08 |
| Danek Medical, Inc. | 1 | 1983-01-14 |
| Orthomedics | 1 | 1981-03-13 |
| Biomet, Inc. | 1 | 1978-03-15 |
Most recent IOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830243 | Warm & Form, Orthopedic Materials | ABDUCTION PILLOW | 1983-03-08 | 42 |
| K823820 | Danek Medical, Inc. | ABDUCTION PILLOW | 1983-01-14 | 28 |
| K810557 | Orthomedics | HIP ABDUCTION SPLINT | 1981-03-13 | 11 |
| K780375 | Biomet, Inc. | PAVLIK HARNESS | 1978-03-15 | 7 |
Recalls for IOZ devices
openFDA lists no recalls for product code IOZ.
Frequently asked questions
What is FDA product code IOZ?
IOZ is the FDA product code for splint, abduction, congenital hip dislocation. It is a Class I device, regulated under 21 CFR 890.3665 and reviewed by the Physical Medicine panel.
What device class is IOZ?
Class I, regulation 21 CFR 890.3665. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IOZ?
Across 4 cleared submissions the average was 22 days from receipt to decision (median 20).
Which companies have the most IOZ clearances?
Warm & Form, Orthopedic Materials (1); Danek Medical, Inc. (1); Orthomedics (1); Biomet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOZ
- Run a recall and safety report across every IOZ manufacturer
- Watch product code IOZ 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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