Internal Hinged Elbow Fixator
The Internal Hinged Elbow Fixator is an orthopedic implant designed to treat joint dislocations, specifically of the elbow joint, by internally stabilizing the joint while allowing controlled motion; the device is intended to be removed once stability is achieved. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZI, with regulation number 888.3030 under the Orthopedic medical specialty, and it carries an implant flag.
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Basic Information
- Product Code
- OZI
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231447 | Double Internal Joint Stabilizer- Elbow | Dec 15, 2023 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K223318 | Internal Joint Stabilizer - Elbow | May 10, 2023 | Substantially Equivalent | Skeletal Dynamics, Inc. |
| K153208 | Internal Joint Stabilizer - Elbow | Dec 31, 2015 | Substantially Equivalent | Skeletal Dynamics, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.