DeviceClearance

Product code NQW— Orthopedic

Vy Spine VyLam Laminoplasty System

Classification name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device class
Class 2
Regulation
21 CFR 888.3050
Advisory panel
Orthopedic
Total cleared
30
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NQW under 21 CFR 888.3050, via openFDA

Market context for product code NQW

FDA has cleared 30 devices under product code NQW between 2004 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NQW

Recent clearances under product code NQW

Data sourced from openFDA. This site is unofficial and independent of the FDA.