UniSyn Hip System

Body, Standard, Cementless, NP, Grit Blast, 30mm, 34mm

Registry build 21.09.26
13manufacturers in China registered for this device type
247catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDI
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Record

Regulatory record for UniSyn Hip System
Listed by Shalby Advanced Technologies, Inc., United States
FDA product code JDI
Device type Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class Class 2
Regulation 21 CFR 888.3350
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Record published 2022-01-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for UniSyn Hip System
Catalogue number Size Status
3461-42622-0 In distribution
3460-41722-0 In distribution
3460-42400-0 In distribution
3427-12017-0 In distribution
3422-11716-0 In distribution
3442-44542-A In distribution
3461-52426-A In distribution
3473-23000-0 In distribution
3426-11013-0 In distribution
3442-44534-A In distribution
3422-11619-0 In distribution
3422-11318-0 In distribution
3425-11731-0 In distribution
3441-13034-0 In distribution
3473-42200-A In distribution
3441-13046-0 In distribution
3441-13038-A In distribution
3427-11619-0 In distribution
3422-11017-0 In distribution
3460-42334-0 In distribution
3426-11820-0 In distribution
3449-03000-0 In distribution
3461-42230-A In distribution
3441-13634-0 In distribution
3461-53026-A In distribution
3425-11826-0 In distribution
3427-11113-0 In distribution
3460-41924-0 In distribution
3425-11321-0 In distribution
3422-11213-0 In distribution
3473-42600-A In distribution
3441-13638-A In distribution
3449-05400-0 In distribution
3441-13042-A In distribution
3425-11121-0 In distribution
3426-11716-0 In distribution
3473-62600-A In distribution
3461-23034-A In distribution
3427-11314-0 In distribution
3461-53234-A In distribution
3427-11716-0 In distribution
3442-45542-A In distribution
3461-42426-A In distribution
3461-42430-0 In distribution
3473-62800-A In distribution
3422-11720-0 In distribution
3461-22230-A In distribution
3473-42800-0 In distribution
3461-52634-A In distribution
3425-11921-0 In distribution
3461-42626-0 In distribution
3427-11816-0 In distribution
3422-11820-0 In distribution
3441-13642-0 In distribution
3426-11213-0 In distribution
3422-11615-0 In distribution
3461-42826-0 In distribution
3461-43030-0 In distribution
3461-23230-A In distribution
3425-11421-0 In distribution
3461-42834-A In distribution
3461-52834-A In distribution
3461-52622-A In distribution
3427-11720-0 In distribution
3427-11213-0 In distribution
3461-22226-A In distribution
3425-12021-0 In distribution
3426-11318-0 In distribution
3473-42200-0 In distribution
3461-42434-0 In distribution
3461-53230-A In distribution
3442-44546-A In distribution
3449-04500-0 In distribution
3473-43000-A In distribution
3427-11217-0 In distribution
3461-53030-A In distribution
3461-22426-A In distribution
3461-22434-A In distribution
3461-22422-A In distribution
3461-42222-A In distribution
3427-11017-0 In distribution
3461-53238-A In distribution
3441-13642-A In distribution
3461-52430-A In distribution
3461-23238-A In distribution
3461-43038-A In distribution
3461-52222-A In distribution
3461-22830-A In distribution
3461-52226-A In distribution
3427-11117-0 In distribution
3422-11515-0 In distribution
3425-11026-0 In distribution
3425-11521-0 In distribution
3442-45534-A In distribution
3461-23038-A In distribution
3473-42400-0 In distribution
3426-11117-0 In distribution
3473-62200-A In distribution
3442-45542-0 In distribution
3461-52826-A In distribution
3461-52630-A In distribution
3422-11414-0 In distribution
3473-42600-0 In distribution
3427-11615-0 In distribution
3425-12126-0 In distribution
3426-11418-0 In distribution
3426-11921-0 In distribution
3473-43000-0 In distribution
3442-44538-0 In distribution
3461-42226-A In distribution
3425-12031-0 In distribution
3425-11931-0 In distribution
3461-52626-A In distribution
3461-43026-0 In distribution
3442-45546-A In distribution
3425-11626-0 In distribution
3425-11621-0 In distribution
3460-41624-0 In distribution
3460-41622-0 In distribution
3422-11217-0 In distribution
3422-11113-0 In distribution
3461-42830-0 In distribution
3461-42434-A In distribution
3442-45534-0 In distribution
3426-12021-0 In distribution
3461-52434-A In distribution
3422-11519-0 In distribution
3461-43034-A In distribution
3426-11414-0 In distribution
3426-11816-0 In distribution
3461-22634-A In distribution
3425-12121-0 In distribution
3461-22826-A In distribution
3461-43026-A In distribution
3441-13046-A In distribution
3460-41724-0 In distribution
3461-42422-0 In distribution
3473-22800-0 In distribution
3461-22834-A In distribution
3425-12026-0 In distribution
3427-11519-0 In distribution
3426-11519-0 In distribution
3425-11926-0 In distribution
3461-43238-A In distribution
3427-11013-0 In distribution
3460-42128-0 In distribution
3422-12017-0 In distribution
3427-11921-0 In distribution
3460-42130-0 In distribution
3461-43034-0 In distribution
3461-42422-A In distribution
3441-13638-0 In distribution
3461-43234-A In distribution
3460-41928-0 In distribution
3461-52230-A In distribution
3473-22600-0 In distribution
3461-43230-A In distribution
3473-22400-0 In distribution
3461-53038-A In distribution
3461-42430-A In distribution
3460-42330-0 In distribution
3425-11831-0 In distribution
3473-63000-A In distribution
3426-11515-0 In distribution
3461-42222-0 In distribution
3442-45538-A In distribution
3425-11326-0 In distribution
3461-42626-A In distribution
3422-11117-0 In distribution
3461-42634-0 In distribution
3427-11917-0 In distribution
3461-22430-A In distribution
3473-62400-A In distribution
3461-23026-A In distribution
3461-23030-A In distribution
3425-11331-0 In distribution
3442-44542-0 In distribution
3461-52422-A In distribution
3461-22622-A In distribution
3425-11526-0 In distribution
3441-13042-0 In distribution
3461-42830-A In distribution
3441-13646-A In distribution
3461-42226-0 In distribution
3441-13646-0 In distribution
3425-11231-0 In distribution
3442-44534-0 In distribution
3426-11017-0 In distribution
3442-44538-A In distribution
3441-13634-A In distribution
3427-11318-0 In distribution
3473-22200-0 In distribution
3426-11615-0 In distribution
3461-22222-A In distribution
3425-11531-0 In distribution
3461-43030-A In distribution
3461-42630-A In distribution
3461-42426-0 In distribution
3426-12017-0 In distribution
3426-11720-0 In distribution
3425-11721-0 In distribution
3461-42634-A In distribution
3427-12021-0 In distribution
3425-11431-0 In distribution
3426-11917-0 In distribution
3461-22626-A In distribution
3449-03600-0 In distribution
3422-11816-0 In distribution
3426-11314-0 In distribution
3473-42800-A In distribution
3461-42622-A In distribution
3441-13034-A In distribution
3441-13038-0 In distribution
3461-42826-A In distribution
3426-11217-0 In distribution
3427-11414-0 In distribution
3461-23234-A In distribution
3425-11021-0 In distribution
3425-11226-0 In distribution
3426-11619-0 In distribution
3425-11126-0 In distribution
3422-11418-0 In distribution
3425-11821-0 In distribution
3461-53034-A In distribution
3425-11631-0 In distribution
3461-42230-0 In distribution
3422-11921-0 In distribution
3422-11013-0 In distribution
3461-52830-A In distribution
3461-22630-A In distribution
3427-11820-0 In distribution
3427-11418-0 In distribution
3425-11726-0 In distribution
3422-11314-0 In distribution
3426-11113-0 In distribution
3425-12131-0 In distribution
3461-42630-0 In distribution
3425-11426-0 In distribution
3442-44546-0 In distribution
3442-45538-0 In distribution
3461-42834-0 In distribution
3442-45546-0 In distribution
3473-42400-A In distribution
3422-12021-0 In distribution
3425-11221-0 In distribution
3422-11917-0 In distribution
3427-11515-0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Zimmer, Inc. 836
R3 Smith & Nephew, Inc. 497
UniSyn® Hip System Consensus Orthopedics, Inc. 247
Reflection Smith & Nephew, Inc. 170
Instrument Howmedica Osteonics Corp 167
Echelon Smith & Nephew, Inc. 159
B-P Total HIP System Endotec, Inc. 151
ZCA® Zimmer, Inc. 149
Omnifit Howmedica Osteonics Corp 149
Ringloc HIP System Biomet Orthopedics 139
Profemur Microport Orthopedics Inc. 113
OSS™ Orthopedic Salvage System Biomet Orthopedics 98

Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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