R3

R3 20 Degree Permanent Trial Liner 44MM Inner Diameter X 76-80MM Outer Diameter

Registry build 21.09.26
5manufacturers in China registered for this device type
554catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDG
Manufacturer City Province Registered as Device types
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Record

Regulatory record for R3
Listed by Smith & Nephew, Inc., United States
FDA product code JDG
Device type Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class Class 2
Regulation 21 CFR 888.3360
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K123598
Record published 2015-08-30
Record revised 2023-09-07 (version 11)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Box of 3
Distribution end date 2018-01-15

Catalogue Numbers

Catalogue numbers for R3
Catalogue number Size Status
71369784 In distribution
E0015686-7 In distribution
71368756 In distribution
E0016576-12 In distribution
71369838 In distribution
E0016434-4 In distribution
71369822 In distribution
71369881 In distribution
E0015623-1 In distribution
E0015571-9 In distribution
71369871 In distribution
71369882 In distribution
E0015571-7 In distribution
E0016574-16 In distribution
E0015686-5 In distribution
E0017806-2 In distribution
71369828 In distribution
E0015572-13 In distribution
E0015712-6 In distribution
71369786 In distribution
E0015712-2 In distribution
E0015571-2 In distribution
E0015570-8 In distribution
E0015686-16 In distribution
E0015596-1 In distribution
E0016574-12 In distribution
E0015572-12 In distribution
71366099 In distribution
E0015560-1 In distribution
71366432 In distribution
E0017006-11 In distribution
E0016575-3 In distribution
E0017006-20 In distribution
E0016464-6 In distribution
E0015569-13 In distribution
71369792 In distribution
71368760 In distribution
E0017007-1 In distribution
E0016465-10 In distribution
71366458 In distribution
71360760 In distribution
E0017006-17 In distribution
71362022 In distribution
71366554 In distribution
71366525 In distribution
E0015683-1 In distribution
E0016464-9 In distribution
71362019 In distribution
71369842 In distribution
E0015683-4 In distribution
E0017006-7 In distribution
E0015569-1 In distribution
71369806 In distribution
71369833 In distribution
71366530 In distribution
E0016573-12 In distribution
E0016465-11 In distribution
71366052 In distribution
71362026 In distribution
E0016434-11 In distribution
E0016575-2 In distribution
71369156 In distribution
71369831 In distribution
71369863 In distribution
71369858 In distribution
71369162 In distribution
E0017006-13 In distribution
71360750 In distribution
71369835 In distribution
E0017806-3 In distribution
71360740 In distribution
E0016575-4 In distribution
71360761 In distribution
E0015572-10 In distribution
71369815 In distribution
E0015572-1 In distribution
E0016573-10 In distribution
E0016461-7 In distribution
71369791 In distribution
E0016465-9 In distribution
71366450 In distribution
E0016464-11 In distribution
71360747 In distribution
E0017611-1 In distribution
E0016575-16 In distribution
E0016576-14 In distribution
71369855 In distribution
71362032 In distribution
71934422 In distribution
E0016934-3 In distribution
E0015793-1 In distribution
71369843 In distribution
71369874 In distribution
71367966 In distribution
E0017754-1 In distribution
E0015686-14 In distribution
71362021 In distribution
E0015596-3 In distribution
71366528 In distribution
71369847 In distribution
71366562 In distribution
71366529 In distribution
E0017006-6 In distribution
71366021 In distribution
71366444 In distribution
71367960 In distribution
71360764 In distribution
E0016577-6 In distribution
E0017007-3 In distribution
71369808 In distribution
71369837 In distribution
E0015569-9 In distribution
E0016577-11 In distribution
71362028 In distribution
E0016464-1 In distribution
E0015686-6 In distribution
E0016461-9 In distribution
E0016573-8 In distribution
71369811 In distribution
71369795 In distribution
E0015686-8 In distribution
E0017006-18 In distribution
71366448 In distribution
E0017304-1 In distribution
71369839 In distribution
71369802 In distribution
E0015712-4 In distribution
E0017946-13 In distribution
71369821 In distribution
71364477 In distribution
71369781 In distribution
71360751 In distribution
71369813 In distribution
E0016291-2 In distribution
71360759 In distribution
E0017006-1 In distribution
E0016577-16 In distribution
E0015571-11 In distribution
71369783 In distribution
E0016461-3 In distribution
71935857 In distribution
E0017006-14 In distribution
E0017007-2 In distribution
71369851 In distribution
E0015572-6 In distribution
71366094 In distribution
71368644 In distribution
71935853 In distribution
E0016577-17 In distribution
71369861 In distribution
71369782 In distribution
E0015570-6 In distribution
71360754 In distribution
71360753 In distribution
E0017611-7 In distribution
E0016577-18 In distribution
E0016576-11 In distribution
E0016433-11 In distribution
E0017408-2 In distribution
71369875 In distribution
E0015596-8 In distribution
E0016896-2 In distribution
E0017806-11 In distribution
E0016574-10 In distribution
71369841 In distribution
E0016433-4 In distribution
E0016461-6 In distribution
E0017806-14 In distribution
71366550 In distribution
71934405 In distribution
71366527 In distribution
E0016465-3 In distribution
71369848 In distribution
E0017006-4 In distribution
71368860 In distribution
E0015596-7 In distribution
E0016433-3 In distribution
E0016461-5 In distribution
71366451 In distribution
E0016201-2 In distribution
71360748 In distribution
E0015571-1 In distribution
71368848 In distribution
71369158 In distribution
E0015712-8 In distribution
E0015569-12 In distribution
71935855 In distribution
71369152 In distribution
E0017006-8 In distribution
E0015596-6 In distribution
E0016577-13 In distribution
E0015596-5 In distribution
71369853 In distribution
E0015571-12 In distribution
E0016461-4 In distribution
E0015572-3 In distribution
E0017517-10 In distribution
E0015572-7 In distribution
E0015569-4 In distribution
E0016434-9 In distribution
E0015572-9 In distribution
E0017671-1 In distribution
E0016433-6 In distribution
E0017806-8 In distribution
71369818 In distribution
71369789 In distribution
E0015570-7 In distribution
E0016934-8 In distribution
E0015572-5 In distribution
E0016934-7 In distribution
71366452 In distribution
E0017612-11 In distribution
71360741 In distribution
71369793 In distribution
71360743 In distribution
71369824 In distribution
71360762 In distribution
71934424 In distribution
E0017517-7 In distribution
71369876 In distribution
E0015596-2 In distribution
E0016574-6 In distribution
E0017408-3 In distribution
71369796 In distribution
E0015686-4 In distribution
E0015570-13 In distribution
71362018 In distribution
E0015571-8 In distribution
E0017806-7 In distribution
E0016355-1 In distribution
71934406 In distribution
71368748 In distribution
71369823 In distribution
E0016574-20 In distribution
E0016433-12 In distribution
E0015712-3 In distribution
71369794 In distribution
71366524 In distribution
71362031 In distribution
E0016465-12 In distribution
71934426 In distribution
71369816 In distribution
E0017806-6 In distribution
71369832 In distribution
E0017408-1 In distribution
E0017576-1 In distribution
E0016461-8 In distribution
E0016934-2 In distribution
E0015571-10 In distribution
71369872 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Emperion Smith & Nephew, Inc. 262
Reflection Smith & Nephew, Inc. 253
Spii Model Lubinus Waldemar Link GmbH & Co. KG 174
Polar Smith & Nephew, Inc. 132
Anthology Smith & Nephew, Inc. 129
Echelon Smith & Nephew, Inc. 122
Synergy Smith & Nephew, Inc. 102
Prosthesis, Hip, Femoral Component, Cemented, Metal Smith & Nephew, Inc. 93
Trigen Smith & Nephew, Inc. 66
Prosthesis Head B Waldemar Link GmbH & Co. KG 62
Corin Taper-Fit Total Hip System Corin Limited 55
SMF Smith & Nephew, Inc. 41

Showing 12 of 71. All products under Prosthesis, Hip, Femoral Component, Cemented, Metal

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