NQP · Class II · 21 CFR 888.3070

FDA Product Code NQP: Posterior Metal/polymer Spinal System, Fusion

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.

Leading manufacturers include Medtronic Sofamor Danek USA, Inc..

22
Total
22
Cleared
130d
Avg days
2004
Since

FDA 510(k) Cleared Posterior Metal/polymer Spinal System, Fusion Devices (Product Code NQP)

22 devices
1–22 of 22
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d

About Product Code NQP - Regulatory Context

NQP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →