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., Paradigm Spine, LLC and 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
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 Jul 02, 2010
DSS STABILIZATION SYSTEM
K101083
Paradigm Spine, LLC
Orthopedic · 74d
Cleared Oct 01, 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234
Zimmer Spine, Inc.
Orthopedic · 70d
Cleared Aug 03, 2009
MODIFICATION TO: DSS STABILIZATION SYSTEM
K091944
Paradigm Spine, LLC
Orthopedic · 34d
Cleared Feb 20, 2009
TRANSITION STABILIZATION SYSTEM
K073439
Globus Medical, Inc.
Orthopedic · 441d
Cleared Nov 28, 2008
DDS STABILIZATION SYSTEM
K080241
Paradigm Spine, LLC
Orthopedic · 302d
Cleared May 02, 2008
DSS STABILIZATION SYSTEM
K080963
Paradigm Spine
Orthopedic · 28d
Cleared Apr 17, 2008
ISOBAR SEMI-RIGID DUAL DAMPENER
K071261
Scient'X
Orthopedic · 349d
Cleared Mar 25, 2008
BIOFLEX
K072321
Biospine Co., Ltd.
Orthopedic · 218d
Cleared Feb 08, 2008
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347
Zimmer Spine, Inc.
Orthopedic · 71d
Cleared Jan 24, 2008
DSS
K072969
Paradigm Spine, LLC
Orthopedic · 94d
Cleared Oct 19, 2007
NGARDE SYSTEM
K072685
N-Spine, Inc.
Orthopedic · 28d
Cleared Oct 05, 2007
ZIMMER DTO IMPLANT
K071879
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Dec 13, 2006
NFIX II PEDICLE SCREW SYSTEM
K061774
N-Spine, Inc.
Orthopedic · 173d
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
Cleared Mar 05, 2004
DYNESYS SPINAL SYSTEM
K031511
Centerpulse Spine-Tech, Inc.
Orthopedic · 296d

About Product Code NQP - Regulatory Context