Resolve Modular Revision Stem

Resolve taper reamer, Ø26×140mm

Registry build 21.09.26
23manufacturers in China registered for this device type
54catalogue 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 Resolve Modular Revision Stem
Listed by United Orthopedic Corp., Taiwan
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-05-16

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, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Resolve Modular Revision Stem
Catalogue number Size Status
9112-3026 In distribution
9112-3027 In distribution
9112-3012 In distribution
9112-3419 In distribution
9112-3616 In distribution
9104-3526 In distribution
9112-3615 In distribution
9104-3624 In distribution
9104-3529 In distribution
9112-3028 In distribution
9112-3618 In distribution
9112-3623 In distribution
9104-3530 In distribution
9112-3018 In distribution
9112-3101 In distribution
9112-3627 In distribution
9112-3013 In distribution
9112-3011 In distribution
9112-3025 In distribution
9112-3620 In distribution
9112-3017 In distribution
9112-3015 In distribution
9104-3528 In distribution
9112-3810 In distribution
9104-3629 In distribution
9112-3613 In distribution
9112-3617 In distribution
9112-3621 In distribution
9112-3625 In distribution
9112-3022 In distribution
9112-3628 In distribution
9104-3628 In distribution
9112-3626 In distribution
9104-3626 In distribution
9112-3622 In distribution
9112-3003 In distribution
9112-3624 In distribution
9112-3421 In distribution
9112-3020 In distribution
9112-3425 In distribution
9104-3627 In distribution
9112-3023 In distribution
9112-3423 In distribution
9112-3014 In distribution
9112-3619 In distribution
9112-3614 In distribution
9104-3625 In distribution
9104-3525 In distribution
9112-3016 In distribution
9112-3019 In distribution
9112-3024 In distribution
9112-3612 In distribution
9112-3021 In distribution
9104-3527 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