Bone Cement, Posterior Screw Augmentation

What Is This Device?

The device is intended to augment the fixation of screws in a posterior spinal system construct.

How Is PML Classified?

Bone Cement, Posterior Screw Augmentation is FDA product code PML, Class 2, 21 CFR 888.3027.

How Does It Reach the US Market?

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.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2023. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.