What is FDA product code NQP?

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.

Orthopedic › ProstheticPosterior Metal/Polymer Spinal System, Fusion

DSS Pedicle Screw Set, Ø5.0 X 35mm

Name: DSS Pedicle screw set, Ø5.0 x 35mm
Brand: DSS Pedicle screw set, Ø5.0 x 35mm

2 catalogue numbers from DPI45035, listed by Paradigm Spine GmbH, Germany, under Posterior Metal/Polymer Spinal System, Fusion. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NQP
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for DSS Pedicle screw set, Ø5.0 x 35mm
Listed by	Paradigm Spine GmbH, Germany
FDA product code	NQP
Device type	Posterior Metal/Polymer Spinal System, Fusion
Device class	Class 2
Regulation	21 CFR 888.3070
Establishment	Specification developer, Manufacturer
Record published	2015-10-01
Record revised	2025-07-02 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for DSS Pedicle screw set, Ø5.0 x 35mm
Catalogue number	Size	Status
DPI45035		In distribution
DPI55035		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CD Horizon® Spinal System	Medtronic Sofamor Danek, Inc.	311
Transition	Globus Medical, Inc.	278
Dynesys®	Zimmer, Inc.	139
Dynesys® Top-Loading System	Zimmer, Inc.	103
Dynesys®	Zimmer Spine, Inc.	29
Zimmer® DTO®	Zimmer, Inc.	15
CD Horizon™ Astute™ Spinal System	Medtronic Sofamor Danek, Inc.	9
Dynesys Dynamic Stabilization System	Highridge Medical, LLC	5
DSS Pedicle screw set, Ø5.0 x 30mm	Paradigm Spine GmbH	2
DSS Pedicle screw set, Ø5.0 x 40mm	Paradigm Spine GmbH	2
DSS Pedicle screw set, Ø7.0 x 45mm	Paradigm Spine GmbH	2
DSS Pedicle screw set, Ø5.0 x 50mm	Paradigm Spine GmbH	2

Showing 12 of 83. All products under Posterior Metal/Polymer Spinal System, Fusion

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K101083	2010-07-02
K091944	2009-08-03
K080241	2008-11-28
K080963	2008-05-02
K072969	2008-01-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.