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 Zimmer Spine, Inc., Medtronic Sofamor Danek USA, Inc. and Medtronic Sofamor Danek.

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
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Jan 11, 2019
CD Horizon™ Spinal System
K182928
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 81d
Cleared Jan 16, 2014
DYNESYS TOP-LOADING SPINAL SYSTEM
K133164
Zimmer Spine, Inc.
Orthopedic · 91d
Cleared Aug 18, 2010
ZIMMER DTO PIN PRESS INSTRUMENT
K101704
Zimmer Spine, Inc.
Orthopedic · 62d
Cleared Oct 01, 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234
Zimmer Spine, Inc.
Orthopedic · 70d
Cleared Feb 20, 2009
TRANSITION STABILIZATION SYSTEM
K073439
Globus Medical, Inc.
Orthopedic · 441d
Cleared Feb 08, 2008
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347
Zimmer Spine, Inc.
Orthopedic · 71d
Cleared Oct 05, 2007
ZIMMER DTO IMPLANT
K071879
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Jul 18, 2006
CD HORIZON SPINAL SYSTEM
K061304
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Apr 06, 2006
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
K060638
Zimmer Spine, Inc.
Orthopedic · 27d
Cleared Mar 11, 2005
MODIFICATION TO DYNESYS SPINAL SYSTEM
K043565
Zimmer Spine, Inc.
Orthopedic · 74d

About Product Code NQP - Regulatory Context