Orthosis, Spine, Plate, Laminoplasty, Metal

What Is It?

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

What Is FDA Product Code NQW?

Orthosis, Spine, Plate, Laminoplasty, Metal is FDA product code NQW, Class 2, 21 CFR 888.3050.

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. Chinese applicants hold 1 clearance under this code; the FDA took 254 days from receipt to decision.