Product Code: NQP FDA class 2 21 CFR 888.3070

Posterior Metal/Polymer Spinal System, Fusion

Orthopedic

The posterior metal and polymer spinal system for fusion is an orthopedic implant consisting of metal and polymer components implanted posteriorly in the thoracic, lumbar, or sacral spine as an adjunct to bone graft fusion, treating acute and chronic instabilities or spinal deformities. It is classified as FDA Class 2 under regulation 888.3070 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag. Product code NQP is not eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: NQP
Device Class: FDA class 2
Regulation Number: 888.3070
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

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