Enduro

Enduro Reamer D11 Shrt.c'less Stem Prep.

Registry build 21.09.26
23manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTO
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
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
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
Changzhou Master Precision Tool Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Showing 12 of 23. All 23 manufacturers in China registered for Reamer

Record

Regulatory record for Enduro
Listed by Aesculap AG, Germany
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-04-24
Record revised 2023-08-22 (version 4)

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

Catalogue Numbers

Catalogue numbers for Enduro
Catalogue number Size Status
NS081R In distribution
NS066R In distribution
NS104R In distribution
NS068R In distribution
NS069R In distribution
NS094R In distribution
NS089R In distribution
NS097R In distribution
NS106R In distribution
NS084R In distribution
NS064R In distribution
NS098R In distribution
NS063R In distribution
NS083R In distribution
NS070R In distribution
NS088R In distribution
NS090R In distribution
NS096R In distribution
NS108R In distribution
NS065R In distribution
NS061R In distribution
NS067R In distribution
NS062R In distribution
NS085R In distribution
NS095R In distribution
NS109R In distribution
NS082R In distribution
NS086R In distribution
NS087R In distribution
NS105R In distribution
NS099R In distribution
NS107R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Trigen Smith & Nephew, Inc. 1,029
Viant Medical, LLC Viant Medical, LLC 825
R3 Smith & Nephew, Inc. 287
Reamer Ortho Development Corp. 259
InSitu Hip System Nextstep Arthropedix 181
Apex Knee System Omni Life Science, Inc. 162
Reamer Synthes Gmbh 152
Reclaim Depuy (Ireland) 138
Reamer Zimmer, Inc. 135
Endo-Model Knee System – Instruments Waldemar Link GmbH & Co. KG 109
DJO Surgical Encore Medical, L.P. 108
Arthrex® Arthrex, Inc. 105

Showing 12 of 1,224. All products under Reamer

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