Who else makes this device?

Name: Transom™
Brand: Transom™

Transom™ · Appliance, Fixation, Spinal Intervertebral Body → Orthopedic

14manufacturers in China registered for this device type

94catalogue numbers in this listing

6510(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 Transom™
Listed by	Neurostructures, Inc., United States
FDA product code	KWQ
Device type	Appliance, Fixation, Spinal Intervertebral Body
Device class	Class 2
Regulation	21 CFR 888.3060
Record published	2015-11-06
Record revised	2025-11-20 (version 4)

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
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Transom™
Catalogue number	Size	Status
11-12-012		In distribution
11-02-028		In distribution
11-14-018		In distribution
11-15-010		In distribution
11-15-016		In distribution
11-03-048		In distribution
11-03-045		In distribution
11-03-063		In distribution
11-90-013		In distribution
11-01-022		In distribution
11-03-060		In distribution
11-90-018		In distribution
11-90-024		In distribution
11-02-046		In distribution
11-03-069		In distribution
11-02-043		In distribution
11-90-000		In distribution
11-14-012		In distribution
11-12-014		In distribution
11-90-015-010		In distribution
11-02-034		In distribution
11-03-054		In distribution
11-90-015-012		In distribution
11-15-018		In distribution
11-01-018		In distribution
11-12-010		In distribution
11-04-064		In distribution
11-01-016		In distribution
11-03-042		In distribution
11-90-001		In distribution
11-03-057		In distribution
11-12-016		In distribution
11-11-012		In distribution
11-02-037		In distribution
11-90-021		In distribution
11-14-010		In distribution
11-04-060		In distribution
11-11-016		In distribution
11-15-012		In distribution
11-15-014		In distribution
11-90-016		In distribution
11-03-051		In distribution
11-16-010		In distribution
11-05-085		In distribution
11-90-015-018		In distribution
11-16-012		In distribution
11-03-066		In distribution
11-16-018		In distribution
11-14-016		In distribution
11-02-024		In distribution
11-90-003		In distribution
11-05-100		In distribution
11-90-012		In distribution
11-13-010		In distribution
11-12-018		In distribution
11-16-014		In distribution
11-01-012		In distribution
11-02-040		In distribution
11-01-014		In distribution
11-05-090		In distribution
11-01-026		In distribution
11-90-019		In distribution
11-04-068		In distribution
11-90-007		In distribution
11-13-012		In distribution
11-05-095		In distribution
11-03-039		In distribution
11-02-030		In distribution
11-01-024		In distribution
11-01-010		In distribution
11-90-010		In distribution
11-90-004		In distribution
11-11-018		In distribution
11-04-080		In distribution
11-90-009		In distribution
11-90-008		In distribution
11-90-015-014		In distribution
11-16-016		In distribution
11-90-005		In distribution
11-90-002		In distribution
11-90-011		In distribution
11-02-026		In distribution
11-14-014		In distribution
11-11-010		In distribution
11-13-014		In distribution
11-13-016		In distribution
11-04-072		In distribution
11-90-015-016		In distribution
11-13-018		In distribution
11-04-084		In distribution
11-01-020		In distribution
11-11-014		In distribution
11-04-076		In distribution
11-02-032		In distribution

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
K200927	2020-07-24
K171112	2017-06-08
K153097	2016-07-15
K142060	2014-11-18
K131374	2013-08-23
K120515	2012-05-23

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.

Transom™