What is FDA product code NKG?

Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Orthopedic › ProstheticPosterior Cervical Screw System

Neon³™ OCT Spinal Stabilization

Name: neon³™ OCT spinal stabilization
Brand: neon³™ OCT spinal stabilization

The neon3 longitudinal rod belongs to a modular posterior system for occipital, cervical and upper thoracic spinal stabilization. It connects within a construct of screw or hook anchors and…

Registry build 21.09.26

The neon3 longitudinal rod belongs to a modular posterior system for occipital, cervical and upper thoracic spinal stabilization. It connects within a construct of screw or hook anchors and interconnecting components. Rod-to-rod and screw-to-screw crosslinks are also included in the system.

The system is intended as an adjunct to fusion at the craniocervical junction, C1 to C7 and T1 to T3. Indications include traumatic fracture or dislocation, instability, deformity, failed fusion, tumors and specified degenerative disease. These uses apply to the assembled construct containing the rod.

Listed Item

OC rod, titanium alloy, Ø 4.0 mm, straight, length 240 mm, screw hole

Limited-Duration Tumor Use

A separate indication permits temporary restoration of spinal integrity without fusion in patients with advanced cervical tumors whose life expectancy is too short for fusion to develop. The implant family contains titanium, titanium alloy and cobalt-chromium components; the longitudinal rod is one structural element within that range.

4manufacturers in China registered for this device type

15catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NKG
Manufacturer	City	Province	Registered as	Device types
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Double Medical Technology Inc.	Xiamen	Fujian	Contract manufacturer	14
Zhejiang Decans Medical Devices Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10

Record

Regulatory record for neon³™ OCT spinal stabilization
Listed by	Ulrich Gmbh & Co. KG, Germany
FDA product code	NKG
Device type	Posterior Cervical Screw System
Device class	Class 2
Regulation	21 CFR 888.3075
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K161032
Record published	2018-02-14
Record revised	2026-05-22 (version 6)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for neon³™ OCT spinal stabilization
Catalogue number	Size	Status
CS 3913-07		In distribution
CS 3913-09		In distribution
CS 3913-04		In distribution
CS 3914-50-16		In distribution
CS 3914-50-08		In distribution
CS 3913-40-04		In distribution
CS 3913-05		In distribution
CS 3915-02		In distribution
CS 3917-10		In distribution
CS 3917-11		In distribution
CS 3917-08		In distribution
CS 3917-23		In distribution
CS 3914-50-10		In distribution
CS 3913-40-03		In distribution
CS 3914-50-14		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bridalveil	Astura Medical	1,718
Proficient™ Posterior Cervical Spine System	Spine Wave, Inc.	1,590
Invictus	Alphatec Spine, Inc.	1,538
Paeon Posterior Cervical Fixation System	Aegis Spine	1,408
ReLine	Nuvasive, Inc.	1,072
PathLoc-C Posterior Cervical Fixation System	L&K Biomed Co., Ltd.	706
Cosy	Signus Medizintechnik Gmbh	550
Yukon OCT Spinal System	VB Spine LLC	451
Astra-OCT Spine System	Spinecraft LLC	440
Symphony	Medos International Sàrl	389
Medyssey Poseidon OCT Spinal Fixation System	Medyssey Co., Ltd.	387
Infinity™ Occipitocervical Upper Thoracic System	Medtronic Sofamor Danek, Inc.	375

Showing 12 of 336. All products under Posterior Cervical Screw System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161032	2016-12-22
K150650	2015-09-24

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.