FDA 510(k) Applications for Medical Device Product Code: NQP (Posterior Metal/Polymer Spinal System, Fusion)

FDA 510(k) Applications for Medical Device Product Code "NQP"
(Posterior Metal/Polymer Spinal System, Fusion)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K072321	BIOSPINE CO., LTD.	BIOFLEX	03/25/2008
K031511	CENTERPULSE SPINE-TECH, INC.	DYNESYS SPINAL SYSTEM	03/05/2004
K073439	GLOBUS MEDICAL INC.	TRANSITION STABILIZATION SYSTEM	02/20/2009
K061304	MEDTRONIC SOFAMOR DANEK	CD HORIZON SPINAL SYSTEM	07/18/2006
K182928	Medtronic Sofamor Danek USA, Inc.	CD HorizonÖ Spinal System	01/11/2019
K203678	Medtronic Sofamor Danek USA, INC.	CD HORIZONÖ Spinal System	01/15/2021
K191066	Medtronic Sofamor Danek, USA Inc.	CD HorizonÖ AstuteÖ Spinal System	10/03/2019
K061774	N SPINE, INC.	NFIX II PEDICLE SCREW SYSTEM	12/13/2006
K072685	N SPINE, INC.	NGARDE SYSTEM	10/19/2007
K080963	PARADIGM SPINE	DSS STABILIZATION SYSTEM	05/02/2008
K101083	PARADIGM SPINE LLC	DSS STABILIZATION SYSTEM	07/02/2010
K080241	PARADIGM SPINE, LLC	DDS STABILIZATION SYSTEM	11/28/2008
K072969	PARADIGM SPINE, LLC	DSS	01/24/2008
K091944	PARADIGM SPINE, LLC	MODIFICATION TO: DSS STABILIZATION SYSTEM	08/03/2009
K071261	SCIENT'X	ISOBAR SEMI-RIGID DUAL DAMPENER	04/17/2008
K060638	ZIMMER SPINE, INC	DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS	04/06/2006
K073347	ZIMMER SPINE, INC	DYNESYS TOP-LOADING SPINAL SYSTEM	02/08/2008
K092234	ZIMMER SPINE, INC	DYNESYS TOP-LOADING SPINAL SYSTEM	10/01/2009
K133164	ZIMMER SPINE, INC	DYNESYS TOP-LOADING SPINAL SYSTEM	01/16/2014
K043565	ZIMMER SPINE, INC	MODIFICATION TO DYNESYS SPINAL SYSTEM	03/11/2005
K071879	ZIMMER SPINE, INC	ZIMMER DTO IMPLANT	10/05/2007
K101704	ZIMMER SPINE, INC.	ZIMMER DTO PIN PRESS INSTRUMENT	08/18/2010