Bone Fixation Cerclage, Sublaminar

What Is This Device?

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

How Is OWI Classified?

Bone Fixation Cerclage, Sublaminar is FDA product code OWI, Class 2, 21 CFR 888.3010.

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 Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.