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.

Capitol · Posterior Cervical Screw System → Orthopedic

Name: Capitol
Brand: Capitol

4manufacturers in China registered for this device type

43catalogue numbers in this listing

4510(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 Capitol
Listed by	Globus Medical, Inc., United States
FDA product code	NKG
Device type	Posterior Cervical Screw System
Device class	Class 2
Regulation	21 CFR 888.3075
Establishment	Manufacturer, Exporter
Record published	2015-11-06
Record revised	2025-07-02 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Label carries	lot or batch number
Sizes	Length 10 to 120 mm; outer diameter 3.5 to 4.5 mm

Catalogue Numbers

Catalogue numbers for Capitol
Catalogue number	Size	Status
111.416	Length 16 mm	In distribution
111.550	Length 50 mm	In distribution
111.318	Length 18 mm	In distribution
111.835	Outer Diameter 3.5 mm	In distribution
111.540	Outer Diameter 4.5 mm	In distribution
111.900	Length 100 mm	In distribution
111.538	Outer Diameter 4.5 mm	In distribution
111.528	Length 28 mm	In distribution
111.830	Length 30 mm	In distribution
111.314	Length 14 mm	In distribution
111.518	Outer Diameter 4.5 mm	In distribution
111.428	Outer Diameter 4 mm	In distribution
111.532	Length 32 mm	In distribution
111.920	Outer Diameter 3.5 mm	In distribution
111.422	Outer Diameter 4 mm	In distribution
111.514	Length 14 mm	In distribution
111.418	Outer Diameter 4 mm	In distribution
111.426	Outer Diameter 4 mm	In distribution
111.510	Length 10 mm	In distribution
111.438	Outer Diameter 4 mm	In distribution
111.332	Length 32 mm	In distribution
111.534	Length 34 mm	In distribution
111.915	Length 115 mm	In distribution
111.840	Length 40 mm	In distribution
111.320	Outer Diameter 3.5 mm	In distribution
111.536	Length 36 mm	In distribution
111.512	Length 12 mm	In distribution
111.548	Length 48 mm	In distribution
111.544	Length 44 mm	In distribution
111.855	Length 55 mm	In distribution
111.875	Length 75 mm	In distribution
111.348	Length 48 mm	In distribution
111.424	Length 24 mm	In distribution
111.326	Length 26 mm	In distribution
111.825	Outer Diameter 3.5 mm	In distribution
111.430	Length 30 mm	In distribution
111.442	Length 42 mm	In distribution
111.334	Outer Diameter 3.5 mm	In distribution
111.850	Outer Diameter 3.5 mm	In distribution
111.845	Length 45 mm	In distribution
111.895	Length 95 mm	In distribution
111.310	Outer Diameter 3.5 mm	In distribution
111.516	Length 16 mm	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
K231850	2024-03-14
K211957	2021-08-18
K161591	2016-09-21
K150552	2015-06-04

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.

Capitol