OZI — Internal Hinged Elbow Fixator Class II

FDA Device Classification

Classification Details

Product Code: OZI
Device Class: Class II
Regulation Number: 888.3030
Submission Type
Review Panel: OR
Medical Specialty: Orthopedic
Implant: Yes

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K231447	skeletal dynamics	Double Internal Joint Stabilizer- Elbow	December 15, 2023
K223318	skeletal dynamics	Internal Joint Stabilizer - Elbow	May 10, 2023
K153208	skeletal dynamics	Internal Joint Stabilizer - Elbow	December 31, 2015