Product code NQP

Device name: Posterior Metal/Polymer Spinal System, Fusion
Medical specialty: Orthopedic
Device class: 2
Regulation number: 888.3070
Review panel: OR
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K203678	CD HORIZON™ Spinal System	Medtronic Sofamor Danek USA, Inc.	2021-01-15
K191066	CD Horizon™ Astute™ Spinal System	Medtronic Sofamor Danek USA, Inc.	2019-10-03
K182928	CD Horizon™ Spinal System	Medtronic Sofamor Danek USA, Inc.	2019-01-11
K133164	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2014-01-16
K101704	ZIMMER DTO PIN PRESS INSTRUMENT	Zimmer Spine, Inc.	2010-08-18
K101083	DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2010-07-02
K092234	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2009-10-01
K091944	MODIFICATION TO: DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2009-08-03
K073439	TRANSITION STABILIZATION SYSTEM	Globus Medical, Inc.	2009-02-20
K080241	DDS STABILIZATION SYSTEM	Paradigm Spine, LLC	2008-11-28
K080963	DSS STABILIZATION SYSTEM	Paradigm Spine	2008-05-02
K071261	ISOBAR SEMI-RIGID DUAL DAMPENER	Scient'X	2008-04-17
K072321	BIOFLEX	Biospine Co., Ltd.	2008-03-25
K073347	DYNESYS TOP-LOADING SPINAL SYSTEM	Zimmer Spine, Inc.	2008-02-08
K072969	DSS	Paradigm Spine, LLC	2008-01-24
K072685	NGARDE SYSTEM	N Spine, Inc.	2007-10-19
K071879	ZIMMER DTO IMPLANT	Zimmer Spine, Inc.	2007-10-05
K061774	NFIX II PEDICLE SCREW SYSTEM	N Spine, Inc.	2006-12-13
K061304	CD HORIZON SPINAL SYSTEM	Medtronic Sofamor Danek	2006-07-18
K060638	DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS	Zimmer Spine, Inc.	2006-04-06
K043565	MODIFICATION TO DYNESYS SPINAL SYSTEM	Zimmer Spine, Inc.	2005-03-11
K031511	DYNESYS SPINAL SYSTEM	Centerpulse Spine-Tech, Inc.	2004-03-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
20763000313344	CD Horizon™ Astute™ Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2020-08-17
20613994170174	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2016-07-08
00613994123985	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123923	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123916	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123909	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123831	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123824	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123800	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123749	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123732	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-09-17
00613994123886	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123640	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123978	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123961	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123954	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123947	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123930	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123657	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123664	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123862	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123855	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123848	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123688	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123695	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123701	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123794	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123770	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-17
00613994123671	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-16
00613994123718	CD HORIZON® Spinal System	MEDTRONIC SOFAMOR DANEK, INC.	2015-07-16

Product code NQP

Related 510(k) Records#

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