Torque Shank

Torque-Shank, T9x100, Cannulated, AO Connector

Registry build 21.09.26
1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LRZ
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62

Record

Regulatory record for Torque Shank
Listed by I.T.S. Gmbh, Austria
FDA product code LRZ
Device type Screwdriver, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-10-25
Record revised 2024-10-01 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Torque Shank
Catalogue number Size Status
54095-100 In distribution
54101-80 In distribution
54098-80 In distribution
54097-80 In distribution
54096-100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bioplate® Bioplate, Inc. 46
Faico CMF System Faico Medical, LLC 40
Orthomed Ortho-MED, Inc. 37
Dental Instrument Cowellmedi Co., Ltd. 26
A.l.p.s. mvX™ Tyber Medical 12
Titanex Vilex LLC 9
Hexagon-Shank I.T.S. Gmbh 5
Leos Cannulated Screw System Tyber Medical 5
Screw Driver I.T.S. Gmbh 4
Screwdriver Shank I.T.S. Gmbh 4
Dynex Vilex LLC 4
Lsss Lockdown Medical Limited 2

Showing 12 of 32. All products under Screwdriver, Surgical

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