Product code OZI— Orthopedic

Internal Joint Stabilizer - Elbow

Classification name: Internal Hinged Elbow Fixator
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Total cleared: 3
First cleared: 2015-12-31
Most recent: 2023-12-15

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.”
— U.S. Food and Drug Administration, device classification record for product code OZI under 21 CFR 888.3030, via openFDA

Market context for product code OZI

FDA has cleared 3 devices under product code OZI between 2015 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20232 clearances
20151 clearance

Top applicants under product code OZI

Skeletal Dynamics, Inc.2 clearances
Skeletal Dynamics, LLC1 clearance

Recent clearances under product code OZI

K231447 — Double Internal Joint Stabilizer- ElbowSkeletal Dynamics, Inc.·2023-12-15
K223318 — Internal Joint Stabilizer - ElbowSkeletal Dynamics, Inc.·2023-05-10
K153208 — Internal Joint Stabilizer - ElbowSkeletal Dynamics, LLC·2015-12-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.