OZI

Internal Hinged Elbow Fixator

Product code

OZI

Device name

Internal Hinged Elbow Fixator

Device class

Class 2

21 CFR

21 CFR 888.3030

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-15.

1 summaries are archived here for direct download.