Journey II

Journey II BCS Constrained Insert Trial SZ 1-2 10MM Right

Registry build 21.09.26
21manufacturers in China registered for this device type
149catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang 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
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Journey II
Listed by Smith & Nephew, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-05-31
Record revised 2023-11-09 (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 Journey II
Catalogue number Size Status
E0017409-1 In distribution
74033857 In distribution
74033903 In distribution
E0015709-2 In distribution
74033895 In distribution
E0018196-15 In distribution
74033883 In distribution
E0017852-6 In distribution
E0016666-1 In distribution
E0018038-1 In distribution
74033863 In distribution
E0018196-5 In distribution
71935116 In distribution
E0018196-14 In distribution
E0018196-18 In distribution
E0015907-3 In distribution
E0015598-1 In distribution
E0015442-1 In distribution
E0016623-1 In distribution
E0018196-12 In distribution
74033907 In distribution
E0018196-11 In distribution
E0017229-1 In distribution
74033875 In distribution
74033896 In distribution
74033835 In distribution
E0017852-9 In distribution
E0017852-8 In distribution
74033851 In distribution
E0017510-1 In distribution
74033873 In distribution
74033847 In distribution
74033864 In distribution
E0018196-8 In distribution
74033852 In distribution
74033841 In distribution
74033887 In distribution
74033881 In distribution
74033885 In distribution
71935117 In distribution
E0017776-2 In distribution
74033871 In distribution
74033901 In distribution
E0017852-7 In distribution
74033844 In distribution
74033837 In distribution
E0018280-1 In distribution
E0016052-1 In distribution
E0017307-2 In distribution
74033838 In distribution
74033846 In distribution
E0017852-1 In distribution
E0018196-7 In distribution
74033862 In distribution
74033843 In distribution
E0015709-1 In distribution
E0015314-13 In distribution
74033892 In distribution
E0018019-2 In distribution
E0018196-16 In distribution
E0018196-17 In distribution
74033872 In distribution
E0016311-2 In distribution
E0016311-1 In distribution
E0018196-3 In distribution
E0015473-1 In distribution
E0017307-1 In distribution
71935119 In distribution
E0015423-1 In distribution
74033897 In distribution
E0018196-6 In distribution
74033855 In distribution
E0017163-1 In distribution
E0015314-14 In distribution
E0015829-2 In distribution
E0017852-2 In distribution
74033882 In distribution
74033836 In distribution
E0016085-1 In distribution
71935118 In distribution
74033898 In distribution
E0017852-5 In distribution
74033878 In distribution
E0017852-11 In distribution
74033845 In distribution
74033833 In distribution
74033908 In distribution
E0017230-1 In distribution
E0017852-10 In distribution
E0015423-3 In distribution
74033904 In distribution
E0015442-2 In distribution
E0017852-12 In distribution
E0017307-3 In distribution
E0017641-1 In distribution
E0016081-1 In distribution
74033894 In distribution
74033884 In distribution
E0016446-1 In distribution
74033856 In distribution
74033859 In distribution
E0016139-2 In distribution
74033834 In distribution
74033874 In distribution
E0015423-2 In distribution
E0015612-1 In distribution
E0018196-10 In distribution
E0016139-3 In distribution
E0017852-4 In distribution
E0018196-2 In distribution
74033839 In distribution
E0016734-1 In distribution
E0015598-2 In distribution
E0016067-1 In distribution
74033865 In distribution
74033831 In distribution
E0016412-1 In distribution
74033888 In distribution
74033832 In distribution
E0015907-4 In distribution
74033893 In distribution
E0015829-3 In distribution
E0017776-1 In distribution
E0016490-1 In distribution
E0018019-1 In distribution
74033876 In distribution
74033842 In distribution
E0018196-20 In distribution
E0017820-1 In distribution
74033861 In distribution
74033877 In distribution
74033891 In distribution
E0018196-19 In distribution
74033853 In distribution
E0018196-1 In distribution
E0018196-9 In distribution
E0018280-2 In distribution
74033886 In distribution
74033902 In distribution
74033858 In distribution
74033867 In distribution
E0017852-3 In distribution
E0015612-2 In distribution
74033866 In distribution
E0018196-13 In distribution
74033906 In distribution
E0018196-4 In distribution
74033905 In distribution
74033854 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

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