DeviceClearance

Product code NQP— Orthopedic

DYNESYS TOP-LOADING SPINAL SYSTEM

Classification name
Posterior Metal/Polymer Spinal System, Fusion
Device class
Class 2
Regulation
21 CFR 888.3070
Advisory panel
Orthopedic
Total cleared
22
First cleared
Most recent

FDA classification definition

“This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.”

— U.S. Food and Drug Administration, device classification record for product code NQP under 21 CFR 888.3070, via openFDA

Market context for product code NQP

FDA has cleared 22 devices under product code NQP between 2004 and 2021, filed by 10 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

Top applicants under product code NQP

Recent clearances under product code NQP

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