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 Code | OZI |
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 |