FDA Product Code OZI: Internal Hinged Elbow Fixator
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.
Leading manufacturers include Skeletal Dynamics, Inc..
3
Total
3
Cleared
154d
Avg days
2015
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Internal Hinged Elbow Fixator Devices (Product Code OZI)
3 devices
Cleared
Dec 15, 2023
Double Internal Joint Stabilizer- Elbow
Skeletal Dynamics, Inc.
Orthopedic
211d
Cleared
May 10, 2023
Internal Joint Stabilizer - Elbow
Skeletal Dynamics, Inc.
Orthopedic
194d
About Product Code OZI - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OZI since 2015, with 3 receiving FDA clearance (average review time: 154 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
OZI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →