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

Black Dimaond Poct

Name: Black Dimaond Poct
Brand: Black Dimaond Poct

The Black Diamond POCT straight rod is a component of a posterior cervical and upper thoracic spinal fixation system. It forms part of a construct used to immobilize and stabilize spinal…

Registry build 21.09.26

The Black Diamond POCT straight rod is a component of a posterior cervical and upper thoracic spinal fixation system. It forms part of a construct used to immobilize and stabilize spinal segments as an adjunct to fusion.

System screws and connecting components lock to rods in configurations selected for the patient’s anatomy. The system’s fusion indications cover C1 through C7 and T1 through T3 for specified traumatic, degenerative, unstable, deformed, tumor-related or previously failed fusion conditions.

Listed Item

3.5x150mm Rod, Straight, Black Diamond POCT

Extended Constructs

Transition or anatomically bent rods can connect the POCT system to compatible occipital cervical thoracic or thoracolumbar stabilization systems with rod diameters from 3.5 to 5.5 mm.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Black Dimaond Poct
Listed by	Osseus Fusion Systems 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, Manufacturer
510(k)	K222107
Record published	2023-06-14
Record revised	2024-08-27 (version 2)

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

Catalogue Numbers

Catalogue numbers for Black Dimaond Poct
Catalogue number	Size	Status
2420-1150		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
K222107	2022-11-03

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.