OrthoMedFlex

Bridgeback Acetabular Reamer, Size 64mm

Registry build 21.09.26
23manufacturers in China registered for this device type
49catalogue 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 OrthoMedFlex
Listed by Orthomedflex LLC
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2016-08-26
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for OrthoMedFlex
Catalogue number Size Status
112-153-251 In distribution
101-167 In distribution
112152264 In distribution
112-152-250 In distribution
112-153-249 In distribution
112-153-246 In distribution
112152265 In distribution
112152266 In distribution
112-153-248 In distribution
112153242 In distribution
112-152-247 In distribution
112153240 In distribution
112153238 In distribution
112-152-254 In distribution
112-152-253 In distribution
112152263 In distribution
101-142 In distribution
112-152-258 In distribution
112-152-256 In distribution
112-153-253 In distribution
112-153-250 In distribution
112-153-247 In distribution
112-152-245 In distribution
112153241 In distribution
112152261 In distribution
112-152-246 In distribution
112-152-249 In distribution
112152268 In distribution
112-153-245 In distribution
112-152-260 In distribution
112-152-259 In distribution
112-152-251 In distribution
112-152-244 In distribution
112-153-252 In distribution
112153236 In distribution
112153237 In distribution
112-153-255 In distribution
112-152-257 In distribution
112153239 In distribution
112153243 In distribution
112-153-244 In distribution
112-152-248 In distribution
101-318 In distribution
112152262 In distribution
112152267 In distribution
112-152-252 In distribution
101-168 In distribution
112-152-255 In distribution
112-153-254 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