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NQP — Posterior Metal/Polymer Spinal System, Fusion Class II

FDA Device Classification

Classification Details

Product Code
NQP
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203678medtronic sofamor danek usaCD HORIZON™ Spinal SystemJanuary 15, 2021
K191066medtronic sofamor danek usaCD Horizon™ Astute™ Spinal SystemOctober 3, 2019
K182928medtronic sofamor danek usaCD Horizon™ Spinal SystemJanuary 11, 2019
K133164zimmer spineDYNESYS TOP-LOADING SPINAL SYSTEMJanuary 16, 2014
K101704zimmer spineZIMMER DTO PIN PRESS INSTRUMENTAugust 18, 2010
K101083paradigm spineDSS STABILIZATION SYSTEMJuly 2, 2010
K092234zimmer spineDYNESYS TOP-LOADING SPINAL SYSTEMOctober 1, 2009
K091944paradigm spineMODIFICATION TO: DSS STABILIZATION SYSTEMAugust 3, 2009
K073439globus medicalTRANSITION STABILIZATION SYSTEMFebruary 20, 2009
K080241paradigm spineDDS STABILIZATION SYSTEMNovember 28, 2008
K080963paradigm spineDSS STABILIZATION SYSTEMMay 2, 2008
K071261scient'xISOBAR SEMI-RIGID DUAL DAMPENERApril 17, 2008
K072321biospine coBIOFLEXMarch 25, 2008
K073347zimmer spineDYNESYS TOP-LOADING SPINAL SYSTEMFebruary 8, 2008
K072969paradigm spineDSSJanuary 24, 2008
K072685n spineNGARDE SYSTEMOctober 19, 2007
K071879zimmer spineZIMMER DTO IMPLANTOctober 5, 2007
K061774n spineNFIX II PEDICLE SCREW SYSTEMDecember 13, 2006
K061304medtronic sofamor danekCD HORIZON SPINAL SYSTEMJuly 18, 2006
K060638zimmer spineDYNESYS SPINAL SYSTEM WITH HA COATED SCREWSApril 6, 2006