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Internal Hinged Elbow Fixator

FDA product code OZI · 2 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3030
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-05-10 – 2023-12-15

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.

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