What is FDA product code NKB?

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Palladian™ · Thoracolumbosacral Pedicle Screw System → Orthopedic

Name: Palladian™
Brand: Palladian™

15manufacturers in China registered for this device type

93catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NKB
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
Shanghai Reach Medical Instrument Co., Ltd.	Shanghai	Shanghai	Manufacturer	30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	25
Double Medical Technology Inc.	Xiamen	Fujian	Contract manufacturer	14

Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System

Record

Regulatory record for Palladian™
Listed by	Neurostructures, Inc., United States
FDA product code	NKB
Device type	Thoracolumbosacral Pedicle Screw System
Device class	Class 2
Regulation	21 CFR 888.3070
Record published	2015-10-16
Record revised	2025-07-02 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Palladian™
Catalogue number	Size	Status
50-10-0002		In distribution
50-90-0005		In distribution
50-01-5550		In distribution
50-01-5535		In distribution
50-03-0030		In distribution
50-04-0004		In distribution
50-06-4025		In distribution
50-90-0023		In distribution
50-07-6550		In distribution
50-06-4535		In distribution
50-05-0004		In distribution
50-03-0070		In distribution
50-01-0001		In distribution
50-90-0047		In distribution
50-01-7535		In distribution
50-01-8570		In distribution
50-90-0001		In distribution
50-04-0003		In distribution
50-90-0011		In distribution
50-01-7540		In distribution
50-01-7545		In distribution
50-06-4545		In distribution
50-90-0018-01		In distribution
50-01-8550		In distribution
50-90-0026		In distribution
50-90-0021-45		In distribution
50-01-5545		In distribution
50-90-0049		In distribution
50-02-0140		In distribution
50-03-0065		In distribution
50-90-0010		In distribution
50-90-0012		In distribution
50-03-0100		In distribution
50-03-0090		In distribution
50-90-0008		In distribution
50-07-7545		In distribution
50-90-0017		In distribution
50-01-6545		In distribution
50-03-0075		In distribution
50-90-0041		In distribution
50-90-0014		In distribution
50-01-7530		In distribution
50-90-0034-85		In distribution
50-05-0003		In distribution
50-01-8580		In distribution
50-10-0001		In distribution
50-01-7555		In distribution
50-03-0040		In distribution
50-01-8540		In distribution
50-03-0060		In distribution
50-01-6535		In distribution
50-01-7550		In distribution
50-90-0021-65		In distribution
50-90-0003		In distribution
50-03-0045		In distribution
50-90-000-03		In distribution
50-07-5550		In distribution
50-01-5555		In distribution
50-01-6530		In distribution
50-03-0055		In distribution
50-02-0100		In distribution
50-90-0013		In distribution
50-90-0006		In distribution
50-90-0016		In distribution
50-90-0018-02		In distribution
50-02-0300		In distribution
50-07-5545		In distribution
50-01-6555		In distribution
50-01-6550		In distribution
50-90-0057		In distribution
50-90-0055		In distribution
50-01-5530		In distribution
50-90-0050		In distribution
50-03-0050		In distribution
50-90-000-02		In distribution
50-03-0080		In distribution
50-05-0002		In distribution
50-07-5540		In distribution
50-10-0003		In distribution
50-04-0002		In distribution
50-07-6540		In distribution
50-07-6545		In distribution
50-90-0007		In distribution
50-01-6540		In distribution
50-90-0009		In distribution
50-06-4525		In distribution
50-90-0053		In distribution
50-90-0020		In distribution
50-03-0035		In distribution
50-90-0004		In distribution
50-02-0120		In distribution
50-01-5540		In distribution
50-01-8545		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
The Jasper Spinal Fixation System	Gbs Commonwealth Co., Ltd.	32,491
Invictus	Alphatec Spine, Inc.	4,722
Vital Spinal Fixation System	Highridge Medical, LLC	4,422
Innoverse Spinal System	CG MedTech Co., Ltd.	4,240
4CIS® Chiron Spinal Fixation System	Alpha AI Co., Ltd.	3,787
LnK Spinal Fixation System	L&K Biomed Co., Ltd.	3,522
Hedjet System	Medyssey Co., Ltd.	3,438
Anax™ 5.5 Spinal System	CG MedTech Co., Ltd.	3,424
Mega Plus MIS Spine System	BK Meditech Co., Ltd.	3,396
ReLine	Nuvasive, Inc.	2,882
Nex-D2	Next Orthosurgical	2,765
AnyPlus Spinal Fixation System	GS Medical Co., Ltd.	2,386

Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K143230	2015-02-25

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.

Palladian™