Fine Osteotomy Implants – Distal Femur
Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws
Unit, Traction, Hip, Non-Powered, Non-Penetrating
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Hebei.
How Is HSR Classified?
Unit, Traction, Hip, Non-Powered, Non-Penetrating is FDA product code HSR, Class 1, 21 CFR 888.5890.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.