Who else makes this device?

Name: Capitol
Brand: Capitol

Capitol · Appliance, Fixation, Spinal Interlaminal → Orthopedic

11manufacturers in China registered for this device type

42catalogue numbers in this listing

7510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWP
Manufacturer	City	Province	Registered as	Device types
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
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
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
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	KWP
Device type	Appliance, Fixation, Spinal Interlaminal
Device class	Class 2
Regulation	21 CFR 888.3050
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 8 to 110 mm; outer diameter 3.5 to 4.5 mm

Catalogue Numbers

Catalogue numbers for Capitol
Catalogue number	Size	Status
111.434	Length 34 mm	In distribution
111.308	Length 8 mm	In distribution
111.336	Length 36 mm	In distribution
111.500		In distribution
111.410	Length 10 mm	In distribution
111.446	Outer Diameter 4 mm	In distribution
111.420	Outer Diameter 4 mm	In distribution
111.880	Length 80 mm	In distribution
111.312	Length 12 mm	In distribution
111.890	Outer Diameter 3.5 mm	In distribution
111.316	Length 16 mm	In distribution
111.444	Length 44 mm	In distribution
111.448	Outer Diameter 4 mm	In distribution
111.546	Outer Diameter 4.5 mm	In distribution
111.340	Length 40 mm	In distribution
111.330	Length 30 mm	In distribution
111.342	Length 42 mm	In distribution
111.870	Outer Diameter 3.5 mm	In distribution
111.910	Length 110 mm	In distribution
111.522	Outer Diameter 4.5 mm	In distribution
111.440	Length 40 mm	In distribution
111.860	Length 60 mm	In distribution
111.436	Length 36 mm	In distribution
111.432	Outer Diameter 4 mm	In distribution
111.520	Length 20 mm	In distribution
111.350	Length 50 mm	In distribution
111.346	Outer Diameter 3.5 mm	In distribution
111.865	Outer Diameter 3.5 mm	In distribution
111.412	Outer Diameter 4 mm	In distribution
111.344	Outer Diameter 3.5 mm	In distribution
111.328	Length 28 mm	In distribution
111.322	Length 22 mm	In distribution
111.414	Length 14 mm	In distribution
111.526	Length 26 mm	In distribution
111.530	Outer Diameter 4.5 mm	In distribution
111.450	Length 50 mm	In distribution
111.524	Outer Diameter 4.5 mm	In distribution
111.338	Outer Diameter 3.5 mm	In distribution
111.885	Outer Diameter 3.5 mm	In distribution
111.542	Outer Diameter 4.5 mm	In distribution
111.905	Length 105 mm	In distribution
111.324	Length 24 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Invictus	Alphatec Spine, Inc.	5,422
ReLine	Nuvasive, Inc.	4,439
CD Horizon® Spinal System	Medtronic Sofamor Danek, Inc.	3,188
Creo	Globus Medical, Inc.	1,992
Apex Spine System	Spinecraft LLC	1,319
LnK Spinal Fixation System	L&K Biomed Co., Ltd.	1,271
Perla ® TL	Spineart SA	1,035
Astra Spine System	Spinecraft LLC	1,003
LineSider	Highridge Medical, LLC	948
Apex-DL Spine System	Spinecraft LLC	909
Revere	Globus Medical, Inc.	875
AccelFix Spinal Fixation System	L&K Biomed Co., Ltd.	841

Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K123783	2013-03-14
K110963	2011-05-05
K102195	2011-01-19
K090565	2009-06-30
K081906	2008-11-14
K052069	2005-08-17
K050391	2005-07-21

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