R3

MIS Acetabular Reamer SZ 56MM

Registry build 21.09.26
23manufacturers in China registered for this device type
287catalogue 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 R3
Listed by Smith & Nephew, Inc., United States
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2017-11-03
Record revised 2023-10-04 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for R3
Catalogue number Size Status
E0015770-9 In distribution
E0018249-7 In distribution
71360286 In distribution
E0015976-1 In distribution
E0017904-1 In distribution
E0017119-2 In distribution
E0017557-19 In distribution
E0017766-3 In distribution
E0015876-1 In distribution
E0016460-3 In distribution
E0017665-3 In distribution
E0017557-17 In distribution
E0016948-4 In distribution
E0017369-2 In distribution
E0017766-4 In distribution
E0017557-15 In distribution
E0018245-10 In distribution
E0017498-6 In distribution
E0017119-5 In distribution
E0017369-5 In distribution
E0018245-12 In distribution
E0016709-7 In distribution
E0015876-9 In distribution
E0017557-16 In distribution
E0016460-8 In distribution
E0015876-17 In distribution
E0017766-9 In distribution
E0017368-4 In distribution
E0016948-3 In distribution
E0016460-10 In distribution
E0015770-7 In distribution
E0015770-16 In distribution
E0017434-9 In distribution
E0015959-6 In distribution
E0016460-9 In distribution
E0015770-2 In distribution
E0018249-11 In distribution
E0017368-5 In distribution
E0017766-6 In distribution
E0016709-17 In distribution
E0015876-16 In distribution
E0016460-4 In distribution
E0018249-2 In distribution
E0017557-8 In distribution
E0017434-2 In distribution
E0015995-5 In distribution
E0017999-3 In distribution
E0016460-15 In distribution
E0015995-7 In distribution
E0015876-2 In distribution
E0016528-20 In distribution
E0017766-12 In distribution
E0018249-9 In distribution
E0016709-8 In distribution
E0018245-11 In distribution
E0015959-1 In distribution
E0017766-15 In distribution
E0018245-7 In distribution
E0015976-6 In distribution
E0015976-2 In distribution
E0017368-9 In distribution
E0016460-2 In distribution
E0016528-17 In distribution
E0018245-5 In distribution
E0015770-1 In distribution
E0016709-12 In distribution
E0017999-6 In distribution
E0016709-13 In distribution
E0017119-3 In distribution
E0018249-14 In distribution
E0016709-6 In distribution
E0017498-1 In distribution
E0016460-17 In distribution
E0017766-11 In distribution
E0017434-8 In distribution
E0017629-1 In distribution
E0015959-17 In distribution
E0015995-12 In distribution
E0018249-5 In distribution
E0015876-19 In distribution
E0015876-6 In distribution
E0017368-3 In distribution
E0015995-4 In distribution
E0017766-1 In distribution
E0015876-13 In distribution
E0016528-5 In distribution
E0017557-6 In distribution
E0017498-7 In distribution
E0016709-1 In distribution
E0017368-6 In distribution
E0015959-18 In distribution
E0018245-9 In distribution
E0016528-7 In distribution
E0017999-12 In distribution
E0016528-6 In distribution
E0016460-19 In distribution
E0015770-13 In distribution
E0017557-4 In distribution
E0015959-9 In distribution
E0017999-7 In distribution
E0017369-8 In distribution
E0018249-12 In distribution
E0015995-6 In distribution
E0016528-12 In distribution
E0016948-2 In distribution
E0018245-3 In distribution
E0018249-6 In distribution
E0017665-11 In distribution
E0015995-9 In distribution
E0016709-4 In distribution
E0016709-11 In distribution
E0018046-4 In distribution
E0018046-2 In distribution
E0016460-1 In distribution
E0015876-4 In distribution
E0017665-12 In distribution
71360293 In distribution
E0018046-7 In distribution
E0017557-18 In distribution
E0017665-4 In distribution
E0016528-11 In distribution
E0015995-10 In distribution
E0015959-16 In distribution
E0017999-9 In distribution
E0015770-6 In distribution
E0015995-13 In distribution
E0016528-18 In distribution
E0016528-14 In distribution
E0017119-4 In distribution
E0015976-3 In distribution
E0017665-1 In distribution
E0017369-9 In distribution
E0017999-10 In distribution
E0016709-14 In distribution
E0018046-10 In distribution
E0015976-4 In distribution
E0016709-15 In distribution
E0015876-10 In distribution
E0017368-1 In distribution
E0018245-2 In distribution
E0015876-3 In distribution
E0016528-2 In distribution
E0018245-6 In distribution
E0016460-14 In distribution
E0017557-9 In distribution
E0018046-9 In distribution
E0016528-4 In distribution
E0016709-5 In distribution
E0016460-12 In distribution
E0015770-3 In distribution
E0018245-1 In distribution
E0015959-4 In distribution
E0017369-3 In distribution
E0015770-8 In distribution
E0015959-12 In distribution
E0018046-6 In distribution
E0015959-10 In distribution
E0018249-10 In distribution
E0015876-14 In distribution
E0017557-12 In distribution
E0015770-10 In distribution
E0016946-1 In distribution
E0015770-17 In distribution
E0016460-16 In distribution
E0016709-16 In distribution
E0016528-10 In distribution
E0016528-15 In distribution
E0017665-6 In distribution
E0016460-6 In distribution
E0017766-5 In distribution
E0016528-16 In distribution
E0018128-1 In distribution
E0017368-7 In distribution
E0017665-5 In distribution
E0015770-19 In distribution
E0017999-2 In distribution
E0017665-10 In distribution
E0015959-15 In distribution
E0016709-9 In distribution
E0015995-2 In distribution
E0015959-7 In distribution
E0015959-5 In distribution
E0017368-10 In distribution
E0017766-8 In distribution
E0015959-8 In distribution
E0018046-8 In distribution
E0017999-5 In distribution
E0018249-4 In distribution
E0017665-7 In distribution
E0018249-1 In distribution
E0015770-11 In distribution
E0017434-4 In distribution
E0017434-5 In distribution
E0017665-2 In distribution
E0015976-7 In distribution
E0015770-14 In distribution
E0017766-13 In distribution
E0017434-3 In distribution
E0015770-18 In distribution
E0018249-15 In distribution
E0016528-9 In distribution
E0017498-4 In distribution
E0018245-4 In distribution
E0018249-3 In distribution
E0015995-1 In distribution
E0016528-19 In distribution
E0017498-2 In distribution
E0017119-1 In distribution
E0017766-7 In distribution
E0015959-2 In distribution
E0015876-7 In distribution
E0016460-18 In distribution
E0017434-1 In distribution
E0018046-1 In distribution
E0016460-5 In distribution
E0017665-8 In distribution
E0015770-12 In distribution
E0017498-5 In distribution
E0017369-6 In distribution
E0017999-8 In distribution
E0018249-16 In distribution
E0017434-6 In distribution
E0017498-3 In distribution
E0016528-3 In distribution
E0015995-3 In distribution
E0015995-8 In distribution
E0015959-14 In distribution
E0017665-9 In distribution
E0018046-12 In distribution
E0016709-18 In distribution
E0015770-15 In distribution
E0018249-13 In distribution
E0015976-9 In distribution
E0016709-19 In distribution
E0017119-6 In distribution
E0015959-11 In distribution
E0017766-2 In distribution
E0015959-13 In distribution
E0017119-7 In distribution
E0017369-1 In distribution
E0016528-13 In distribution
E0017999-4 In distribution
E0017557-11 In distribution
E0018249-8 In distribution
E0017434-7 In distribution
E0016460-7 In distribution
E0016528-8 In distribution
E0015876-8 In distribution
E0015976-5 In distribution
E0015876-5 In distribution

Showing 250 of 287 catalogue numbers.

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
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
Arthrex Provision 98

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