What Is It?
Stabilization or correction of spinal deformities without the use of fusion.
What Is FDA Product Code PGM?
Growing Rod System is FDA product code PGM, Class 2, 21 CFR 888.3070.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.