Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL

Driver Assy, Female, Heptagon, 1/2", for Silhouette by Zimmer

Registry build 21.09.26
18manufacturers in China registered for this device type
72catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXX
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
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Autocam Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82

Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver

Record

Regulatory record for Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL
Listed by Shukla Medical
FDA product code HXX
Device type Screwdriver
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2021-07-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization

Catalogue Numbers

Catalogue numbers for Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL
Catalogue number Size Status
SDR857 In distribution
SDR869 In distribution
SDR729 In distribution
SDR789 In distribution
SDR864 In distribution
SDR745 In distribution
SDR709 In distribution
SDR727 In distribution
SDR705 In distribution
SDR785 In distribution
SDR866 In distribution
SDR720 In distribution
SDR863 In distribution
SDR752 In distribution
SDR872 In distribution
SDR788 In distribution
SDR868 In distribution
SDR764 In distribution
SDR855 In distribution
SDR874 In distribution
SDR733 In distribution
SDR753 In distribution
SDR766 In distribution
SDR760 In distribution
SDR784 In distribution
SDR865 In distribution
SDR805 In distribution
SDR754 In distribution
SDR851 In distribution
SDR879 In distribution
SDR782 In distribution
SDR867 In distribution
SDR787 In distribution
SDR731 In distribution
SDR712 In distribution
SDR744 In distribution
SDR860 In distribution
SDR743 In distribution
SDR862 In distribution
SDR762 In distribution
SDR726 In distribution
SDR728 In distribution
SDR876 In distribution
SDR856 In distribution
SDR765 In distribution
SDR721 In distribution
SDR741 In distribution
SDR873 In distribution
SDR763 In distribution
SDR730 In distribution
SDR751 In distribution
SDR732 In distribution
SDR710 In distribution
SDR859 In distribution
SDR759 In distribution
SDR773 In distribution
SDR711 In distribution
SDR783 In distribution
SDR761 In distribution
SDR777 In distribution
SDR861 In distribution
SDR776 In distribution
SDR878 In distribution
SDR811 In distribution
SDR707 In distribution
SDR850 In distribution
SDR858 In distribution
SDR708 In distribution
SDR734 In distribution
SDR713 In distribution
SDR877 In distribution
SDR786 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tecomet Tecomet, Inc. 939
Screwdriver Synthes Gmbh 485
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 371
Screwdriver Medtronic Sofamor Danek, Inc. 197
Level ONE KLS-Martin L.P. 153
Surgical Instrument Jeil Medical Corporation 116
Invictus Alphatec Spine, Inc. 115
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 110
Bradshaw Medical Inc. Bradshaw Medical Inc. 109
Screwdriver Depuy Spine, Inc. 99
Generic Surgical Instruments CTL Medical Corporation 93
Surgical Direct Surgical Direct, Inc. 85

Showing 12 of 1,263. All products under Screwdriver

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer