Medtronic Reusable Instruments

Countertorque EX0518023 5.5 MAS RD Pushr

Registry build 21.09.26
14manufacturers in China registered for this device type
85catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Shandong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXC
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
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30

Showing 12 of 14. All 14 manufacturers in China registered for Wrench

Record

Regulatory record for Medtronic Reusable Instruments
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HXC
Device type Wrench
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2022-10-08
Record revised 2025-11-13 (version 2)

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
Distribution end date 2026-04-27
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medtronic Reusable Instruments
Catalogue number Size Status
X0403013 In distribution
Y9339040 In distribution
EX0410070 In distribution
EX1121003 In distribution
EX0618042 In distribution
EX0521014 In distribution
EX0220062 In distribution
EX0824556 In distribution
EX0923006 In distribution
EX0518023 In distribution
X1002018 In distribution
X8361546 In distribution
EX0412019 In distribution
X0696-020 In distribution
EX0720015 In distribution
9339005 In distribution
X808-546 In distribution
EX1118001 In distribution
X0604300 In distribution
EX0518024 In distribution
X1098-021 In distribution
X5597120 In distribution
X0916099 In distribution
EX1022001 In distribution
EX0220061 In distribution
X0115036 In distribution
X1201009 In distribution
EX0118019 In distribution
84696H In distribution
EX1113130 In distribution
84679 In distribution
EX0520011 In distribution
EX0122026 In distribution
858-990 In distribution
X0602016 In distribution
EX0618040 In distribution
EX1018016 In distribution
EX1125009 In distribution
EX0518022 In distribution
X0915010 In distribution
X0998-032 In distribution
EX0521016 In distribution
X0397-018 In distribution
8616002 In distribution
EX0925002 In distribution
EX0918013 In distribution
EX0824456 In distribution
836-050 In distribution
X8680046 In distribution
X1210029 In distribution
X808-586 In distribution
EX0520010 In distribution
X0103112 In distribution
X0101001 In distribution
EX0618041 In distribution
X0319038 In distribution
EX0521027 In distribution
EX1119040 In distribution
X1001009 In distribution
X1094-016 In distribution
X1094-015 In distribution
808-553 In distribution
EX0521015 In distribution
80615528 In distribution
EX0824475 In distribution
X0397-017 In distribution
X0621004 In distribution
X0622001 In distribution
8239002 In distribution
X0602014 In distribution
X0324055 In distribution
EX0119026 In distribution
X8680047 In distribution
80615515 In distribution
EX0419010 In distribution
EX0421015 In distribution
X1018030 In distribution
X0602015 In distribution
5484285 In distribution
X6550024 In distribution
X0797-031 In distribution
X0199-037 In distribution
XIB0403024 Withdrawn
X0911158 Withdrawn
X0514010 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wrench Synthes Gmbh 80
Helmut Zepf Helmut Zepf Medizintechnik Gmbh 26
Smart Correction Wishbone Medical Inc. 25
Pinnacle Gription TF Depuy (Ireland) 23
Karl Schumacher Karl Schumacher Dental, LLC 21
Mega Plus Spine System BK Meditech Co., Ltd. 20
Kalitec Universal Instruments Kalitec Direct, LLC 19
Medtronic Resuable Instruments Medtronic Sofamor Danek, Inc. 17
X FIX Biomet Orthopedics 15
Global Steptech APG Depuy Orthopaedics, Inc. 14
Wrench Zimmer, Inc. 14
Pinnacle Depuy (Ireland) 13

Showing 12 of 388. All products under Wrench

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