Medtronic Reusable Instruments

Pusher 5584235 5.5/6.0 ROD Pusher - EU

Registry build 21.09.26
6manufacturers in China registered for this device type
14catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HXO
Manufacturer City Province Registered as Device types
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25

Record

Regulatory record for Medtronic Reusable Instruments
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HXO
Device type Pusher, Socket
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2022-10-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medtronic Reusable Instruments
Catalogue number Size Status
EX0213001 In distribution
5484231 In distribution
X1096-020 In distribution
5584235 In distribution
EX0311220 In distribution
EX1018024 In distribution
X1101015 In distribution
5484235 In distribution
EX1111001 In distribution
X0103036 In distribution
5484317 In distribution
EX0721128 In distribution
X836-021 In distribution
EX1013014 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spirofit Pinnacle Depuy (Ireland) 17
Pinnacle Depuy (Ireland) 14
Pusher, Socket Zimmer, Inc. 11
Mega Spine System BK Meditech Co., Ltd. 9
Kheiron S.m.a.i.o 5
MEGA5.5 Spine System BK Meditech Co., Ltd. 5
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 4
Link Instruments – Fixation instruments Waldemar Link GmbH & Co. KG 3
Affiniti Tornier Inc. 3
Liner Pusher Head Biomet UK Ltd. 3
Pusher, Socket Doppkon Gmbh & Co. KG 3
Pusher, Socket Synthes Gmbh 3

Showing 12 of 58. All products under Pusher, Socket

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