FDA product code OZI: Internal Hinged Elbow Fixator
OZI is the FDA product code for internal hinged elbow fixator. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OZI, 2 in the last five years, from 2 different applicants. The average 510(k) review took 154 days (median 194).
Definition
The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
Classification
| Field | Value |
|---|---|
| Device name | Internal Hinged Elbow Fixator |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OZI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 202 |
Compare with all 510(k) review times · Search every OZI clearance
Top OZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Skeletal Dynamics, Inc. | 2 | 2023-12-15 |
| Skeletal Dynamics, LLC | 1 | 2015-12-31 |
Most recent OZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231447 | Skeletal Dynamics, Inc. | Double Internal Joint Stabilizer- Elbow | 2023-12-15 | 211 |
| K223318 | Skeletal Dynamics, Inc. | Internal Joint Stabilizer - Elbow | 2023-05-10 | 194 |
| K153208 | Skeletal Dynamics, LLC | Internal Joint Stabilizer - Elbow | 2015-12-31 | 56 |
Recalls for OZI devices
openFDA lists no recalls for product code OZI.
Frequently asked questions
What is FDA product code OZI?
OZI is the FDA product code for internal hinged elbow fixator. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is OZI?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code OZI?
Across 3 cleared submissions the average was 154 days from receipt to decision (median 194).
Which companies have the most OZI clearances?
Skeletal Dynamics, Inc. (2); Skeletal Dynamics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OZI
- Run a recall and safety report across every OZI manufacturer
- Watch product code OZI 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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