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U.S. Department of Health and Human Services

Product Classification
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Device internal hinged elbow fixator
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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.
Physical State The hinged internal fixator consists of titanium and cobalt chromium components
Technical Method The hinged internal fixator secures the elbow joint by means of a plate and screws on the ulna attached to a pin that is inserted into the humerus.
Target Area The hinged internal fixator is intended for use in the elbow joint.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOZI
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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