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.

Connector · Posterior Cervical Screw System → Orthopedic

Name: Connector
Brand: Connector

4manufacturers in China registered for this device type

28catalogue numbers in this listing

2recalls on this 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 Connector
Listed by	Orthofix US LLC, United States
FDA product code	NKG
Device type	Posterior Cervical Screw System
Device class	Class 2
Regulation	21 CFR 888.3075
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K211710
Record published	2026-07-17

Specifications

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

Catalogue Numbers

Catalogue numbers for Connector
Catalogue number	Size	Status
79-6150		In distribution
79-2160		In distribution
79-2605		In distribution
79-2165		In distribution
79-2120		In distribution
79-2110		In distribution
79-2125		In distribution
79-2150		In distribution
79-2140		In distribution
79-8150		In distribution
79-2003		In distribution
79-2130		In distribution
79-2615		In distribution
79-2805		In distribution
79-6300		In distribution
79-2105		In distribution
79-2600		In distribution
79-2815		In distribution
79-2100		In distribution
79-2800		In distribution
79-8300		In distribution
79-2135		In distribution
79-2115		In distribution
79-2855		In distribution
79-2300		In distribution
79-2655		In distribution
79-2155		In distribution
79-2002		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

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Connector
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Orthofix US LLC	UDI-DI	2018-02-23	Class II	Nonconforming Material/Component	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf	397 units	2019-06-18
Orthofix US LLC	UDI-DI	2018-02-23	Class II	Nonconforming Material/Component	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf	188 units	2019-06-18

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.

Connector