What Is It?
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
How Is OVD Classified?
Intervertebral Fusion Device With Integrated Fixation, Lumbar is FDA product code OVD, Class 2, 21 CFR 888.3080.
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 36 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Device Design (10), Process control (3) and Component design/selection (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.