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.

Reform Midline Cortical Screw System · Thoracolumbosacral Pedicle Screw System → Orthopedic

Name: Reform Midline Cortical Screw System
Brand: Reform Midline Cortical Screw System

15manufacturers in China registered for this device type

242catalogue numbers in this listing

6510(k) clearances naming this product code

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 Reform Midline Cortical Screw System
Listed by	Precision Spine, Inc., United States
FDA product code	NKB
Device type	Thoracolumbosacral Pedicle Screw System
Device class	Class 2
Regulation	21 CFR 888.3070
Establishment	Manufacturer
510(k)	K173130
Record published	2019-05-07
Record revised	2025-11-20 (version 6)

Specifications

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

Catalogue Numbers

Catalogue numbers for Reform Midline Cortical Screw System
Catalogue number	Size	Status
59-BP-4545		In distribution
59-LO-0120		In distribution
59-BP-8535		In distribution
59-SC-5150		In distribution
59-BK-0445		In distribution
59-BC-5540		In distribution
59-BK-0455		In distribution
59-LC-5090		In distribution
59-BC-9550		In distribution
59-LC-5120		In distribution
59-SC-0402		In distribution
59-BC-5060		In distribution
59-LO-0150		In distribution
59-BC-9590		In distribution
59-BK-0506		In distribution
59-BP-7535		In distribution
59-SC-5300		In distribution
59-BP-5525		In distribution
59-BC-4545		In distribution
59-BC-7545		In distribution
59-BP-8590		In distribution
59-LO-0130		In distribution
59-LC-5110		In distribution
59-BP-9500		In distribution
59-BP-6550		In distribution
59-BP-9550		In distribution
59-BC-8590		In distribution
59-CC-0033		In distribution
59-LC-5065		In distribution
59-SC-5100		In distribution
59-BC-8535		In distribution
59-BC-5050		In distribution
59-SC-5120		In distribution
59-LC-5080		In distribution
59-BC-9545		In distribution
59-BC-7580		In distribution
59-BP-9570		In distribution
59-BC-6560		In distribution
59-BK-1011		In distribution
59-LO-0140		In distribution
59-BP-7540		In distribution
59-BC-5545		In distribution
59-BP-7560		In distribution
59-BC-8511		In distribution
59-BP-9555		In distribution
59-CC-0047		In distribution
59-BC-8512		In distribution
59-BC-6530		In distribution
59-BP-8511		In distribution
59-BP-5060		In distribution
59-LO-1120		In distribution
59-SC-0505		In distribution
59-SC-0403		In distribution
59-BC-1055		In distribution
59-BP-5055		In distribution
59-LC-5060		In distribution
59-LC-5070		In distribution
59-BC-7570		In distribution
59-AA-0103		In distribution
59-BC-8550		In distribution
59-BC-7535		In distribution
59-BP-6540		In distribution
59-SC-5060		In distribution
59-DA-0103		In distribution
59-BP-5050		In distribution
59-BC-6535		In distribution
59-SC-0475		In distribution
59-LO-0220		In distribution
59-DA-0203		In distribution
59-LO-0240		In distribution
59-BP-1050		In distribution
59-DA-0201		In distribution
59-BC-5525		In distribution
59-BC-4530		In distribution
59-BC-7530		In distribution
59-BP-8560		In distribution
59-LC-5075		In distribution
59-BP-1000		In distribution
59-BP-6545		In distribution
59-SC-5080		In distribution
59-BK-0507		In distribution
59-SC-5040		In distribution
59-BC-1040		In distribution
59-DA-0105		In distribution
59-LC-5040		In distribution
59-BK-1013		In distribution
59-BC-5025		In distribution
59-BC-7555		In distribution
59-LC-5045		In distribution
59-DA-0202		In distribution
59-LC-5050		In distribution
59-BP-1090		In distribution
59-BC-1012		In distribution
59-BC-1000		In distribution
59-BC-6525		In distribution
59-BP-8555		In distribution
59-BC-6555		In distribution
59-BP-7555		In distribution
59-BP-1012		In distribution
59-BP-9545		In distribution
59-SC-0450		In distribution
59-BP-8570		In distribution
59-BP-5560		In distribution
59-SC-0465		In distribution
59-BC-8545		In distribution
59-BP-1045		In distribution
59-BC-9512		In distribution
59-LO-1240		In distribution
59-AA-0102		In distribution
59-BP-9511		In distribution
59-SC-0506		In distribution
59-BK-0450		In distribution
59-BP-7550		In distribution
59-BC-8570		In distribution
59-BC-1011		In distribution
59-BP-8500		In distribution
59-BC-6545		In distribution
59-BP-8540		In distribution
59-SC-0401		In distribution
59-BP-4535		In distribution
59-BC-8580		In distribution
59-BC-9560		In distribution
59-BK-0403		In distribution
59-BK-0505		In distribution
59-DA-0204		In distribution
59-BP-1070		In distribution
59-BC-9511		In distribution
59-SC-0455		In distribution
59-BK-0404		In distribution
59-BP-5540		In distribution
59-BP-6530		In distribution
59-BP-5035		In distribution
59-BP-5550		In distribution
59-BP-9540		In distribution
59-BP-6560		In distribution
59-BP-7570		In distribution
59-SC-3000		In distribution
59-BP-7580		In distribution
59-LC-5100		In distribution
59-BP-1060		In distribution
59-BC-5535		In distribution
59-LS-0100		In distribution
59-BP-5545		In distribution
59-LO-1230		In distribution
59-BP-8580		In distribution
59-BC-6550		In distribution
59-BK-1012		In distribution
59-BP-5530		In distribution
59-BC-8540		In distribution
59-MT-0301		In distribution
59-BK-0465		In distribution
59-BP-5040		In distribution
59-BC-9570		In distribution
59-DA-0205		In distribution
59-BC-5055		In distribution
59-BP-7545		In distribution
59-CC-0038		In distribution
59-BC-9555		In distribution
59-BP-1040		In distribution
59-BC-5035		In distribution
59-SC-0507		In distribution
59-BC-6540		In distribution
59-SC-1000		In distribution
59-BK-2000		In distribution
59-LO-1130		In distribution
59-BK-0402		In distribution
59-BC-5560		In distribution
59-BP-5030		In distribution
59-BC-5550		In distribution
59-BP-9560		In distribution
59-BC-5045		In distribution
59-BC-5530		In distribution
59-BP-9580		In distribution
59-BC-1090		In distribution
59-BC-1045		In distribution
59-LO-0230		In distribution
59-AA-0101		In distribution
59-BP-5535		In distribution
59-BP-4530		In distribution
59-BC-5555		In distribution
59-LO-0250		In distribution
59-DA-0102		In distribution
59-SC-0504		In distribution
59-BC-7540		In distribution
59-SC-2000		In distribution
59-SC-5500		In distribution
59-SC-5200		In distribution
59-BP-9512		In distribution
59-SC-0404		In distribution
59-BP-6535		In distribution
59-BK-0475		In distribution
59-BC-8555		In distribution
59-BC-9500		In distribution
59-BK-1014		In distribution
59-BC-1060		In distribution
59-BP-1080		In distribution
59-BK-3000		In distribution
59-BP-6525		In distribution
59-BC-7550		In distribution
59-BC-4540		In distribution
59-BP-5555		In distribution
59-DA-0207		In distribution
59-BC-9580		In distribution
59-DA-0206		In distribution
59-BC-1070		In distribution
59-BC-8500		In distribution
59-BP-1055		In distribution
59-BP-8550		In distribution
59-BC-7560		In distribution
59-BC-5030		In distribution
59-BP-4525		In distribution
59-BC-5040		In distribution
59-CC-0030		In distribution
59-BC-9540		In distribution
59-SC-5400		In distribution
59-BK-0401		In distribution
59-LO-1220		In distribution
59-BK-0504		In distribution
59-BC-4535		In distribution
59-BP-9590		In distribution
59-BP-5025		In distribution
59-LO-1140		In distribution
59-DA-0106		In distribution
59-DA-0104		In distribution
59-LC-5035		In distribution
59-LC-5055		In distribution
59-BP-8512		In distribution
59-SC-0445		In distribution
59-BP-6555		In distribution
59-SC-5600		In distribution
59-BC-4525		In distribution
59-BC-8560		In distribution
59-BP-1011		In distribution
59-BP-4540		In distribution
59-DA-0208		In distribution
59-BP-7530		In distribution
59-BC-1050		In distribution
59-MT-0302		In distribution
59-LO-1150		In distribution
59-BC-1080		In distribution
59-DA-0101		In distribution
59-BP-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
K242297	2024-12-17
K200303	2020-05-19
K173130	2017-12-19
K151422	2015-08-21
K150856	2015-07-07
K143248	2014-12-19

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.

Reform Midline Cortical Screw System