Who else makes this device?

Name: Diamond
Brand: Diamond

Diamond · Appliance, Fixation, Spinal Intervertebral Body → Orthopedic

14manufacturers in China registered for this device type

108catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWQ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
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
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
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
Double Medical Technology Inc.	Xiamen	Fujian	Contract manufacturer	14

Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body

Record

Regulatory record for Diamond
Listed by	Spinal Elements, Inc., United States
FDA product code	KWQ
Device type	Appliance, Fixation, Spinal Intervertebral Body
Device class	Class 2
Regulation	21 CFR 888.3060
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2017-05-18
Record revised	2025-11-20 (version 8)

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, manufacturing date
Distribution end date	2021-12-08

Catalogue Numbers

Catalogue numbers for Diamond
Catalogue number	Size	Status
10000-1-32		Withdrawn
10003-VS-4016		Withdrawn
10000-3-56		Withdrawn
6-2-45		Withdrawn
6-3-71		Withdrawn
6-2-39		Withdrawn
6-F-4312		Withdrawn
6-F-4314		Withdrawn
10000-3-68		Withdrawn
6-1-22		Withdrawn
6-VS-4314		Withdrawn
6-1-24		Withdrawn
10003-V-4318		Withdrawn
10003-V-4312		Withdrawn
6-V-4312		Withdrawn
6-VS-4012		Withdrawn
6-3-68		Withdrawn
10003-F-4018		Withdrawn
10003-V-4012		Withdrawn
6-1-32		Withdrawn
10000-2-45		Withdrawn
10000-4-72		Withdrawn
6-2-48		Withdrawn
6-2-51		Withdrawn
6-3-65		Withdrawn
10000-4-76		Withdrawn
10000-4-68		Withdrawn
6-3-56		Withdrawn
10000-1-24		Withdrawn
10003-V-4314		Withdrawn
6-F-4016		Withdrawn
10003-VS-4316		Withdrawn
10003-F-4012		Withdrawn
10003-VS-4014		Withdrawn
6-V-4316		Withdrawn
6-VS-4312		Withdrawn
10000-3-65		Withdrawn
6-4-88		Withdrawn
6-4-72		Withdrawn
6-1-28		Withdrawn
10000-3-53		Withdrawn
10003-F-4312		Withdrawn
10000-2-51		Withdrawn
6-1-34		Withdrawn
10003-VS-4318		Withdrawn
6-4-80		Withdrawn
10000-4-84		Withdrawn
6-1-26		Withdrawn
6-F-4318		Withdrawn
6-4-84		Withdrawn
10000-3-77		Withdrawn
6-2-54		Withdrawn
6-3-62		Withdrawn
10000-4-88		Withdrawn
6-4-76		Withdrawn
10003-VS-4018		Withdrawn
6-F-4012		Withdrawn
6-2-42		Withdrawn
6-V-4014		Withdrawn
6-F-4014		Withdrawn
10000-3-59		Withdrawn
10003-V-4014		Withdrawn
10003-F-4318		Withdrawn
6-V-4012		Withdrawn
10000-1-22		Withdrawn
10003-F-4014		Withdrawn
10003-V-4018		Withdrawn
6-4-92		Withdrawn
6-1-30		Withdrawn
10003-VS-4314		Withdrawn
10000-4-92		Withdrawn
10003-V-4316		Withdrawn
6-V-4016		Withdrawn
10000-1-28		Withdrawn
6-V-4318		Withdrawn
10003-F-4016		Withdrawn
6-VS-4018		Withdrawn
6-3-53		Withdrawn
6-V-4314		Withdrawn
10003-VS-4312		Withdrawn
6-VS-4014		Withdrawn
6-3-77		Withdrawn
6-VS-4016		Withdrawn
6-2-36		Withdrawn
10000-4-80		Withdrawn
10003-V-4016		Withdrawn
10000-3-71		Withdrawn
6-4-68		Withdrawn
10000-2-48		Withdrawn
6-F-4316		Withdrawn
10003-VS-4012		Withdrawn
6-VS-4318		Withdrawn
10000-2-36		Withdrawn
10000-1-34		Withdrawn
10000-2-39		Withdrawn
6-V-4018		Withdrawn
10000-2-42		Withdrawn
6-3-74		Withdrawn
6-VS-4316		Withdrawn
10000-1-30		Withdrawn
10000-1-26		Withdrawn
10003-F-4314		Withdrawn
10000-2-54		Withdrawn
6-F-4018		Withdrawn
10000-3-62		Withdrawn
10003-F-4316		Withdrawn
10000-3-74		Withdrawn
6-3-59		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ReLine	Nuvasive, Inc.	2,998
CD Horizon® Spinal System	Medtronic Sofamor Danek, Inc.	2,568
Creo	Globus Medical, Inc.	1,765
AccelFix Spinal Fixation System	L&K Biomed Co., Ltd.	1,755
Ozark Cervical Plate System	VB Spine LLC	1,460
Sirion	Astura Medical	1,246
Apex Spine System	Spinecraft LLC	1,187
AnyPlus Spinal Fixation System	GS Medical Co., Ltd.	986
Astra Spine System	Spinecraft LLC	970
Zavation	Zavation	966
ACP	Nuvasive, Inc.	918
Polaris™ 5.5 Spinal System	Biomet Spine	877

Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231593	2023-08-02
K201029	2020-06-17
K101848	2010-10-14
K081418	2008-07-14

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.

Diamond