DJO Surgical

Special, RSP Half Moon Glenoid Reamer RIM Planer

Registry build 21.09.26
23manufacturers in China registered for this device type
68catalogue 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 DJO Surgical
Listed by DJO, LLC, United States
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-06-26
Record revised 2023-10-04 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for DJO Surgical
Catalogue number Size Status
802-01-071 In distribution
803-04-021 In distribution
804-25-143 In distribution
803-99-001 In distribution
804-01-036 In distribution
804-06-013 In distribution
804-01-037 In distribution
804-02-085 In distribution
804-06-012 In distribution
804-00-031 In distribution
802-01-078 In distribution
802-01-082 In distribution
802-01-079 In distribution
S-201790 In distribution
804-02-015 In distribution
800-01-172 In distribution
804-25-044 In distribution
803-99-003 In distribution
804-05-090 In distribution
802-01-081 In distribution
800-01-005 In distribution
803-00-098 In distribution
800-01-169 In distribution
803-00-090 In distribution
804-25-142 In distribution
803-03-001 In distribution
804-25-146 In distribution
803-50-002 In distribution
803-00-088 In distribution
804-05-088 In distribution
804-05-086 In distribution
804-00-029 In distribution
804-05-091 In distribution
803-00-035 In distribution
802-01-073 In distribution
802-01-072 In distribution
804-25-045 In distribution
802-01-084 In distribution
804-00-033 In distribution
803-99-015 In distribution
804-25-145 In distribution
802-01-083 In distribution
800-01-166 In distribution
800-01-167 In distribution
804-25-042 In distribution
804-25-043 In distribution
804-00-039 In distribution
804-01-060 In distribution
800-01-171 In distribution
803-00-089 In distribution
800-01-170 In distribution
803-00-087 In distribution
804-02-014 In distribution
804-00-002 In distribution
804-05-087 In distribution
804-00-035 In distribution
803-00-099 In distribution
803-00-086 In distribution
802-01-077 In distribution
800-01-168 In distribution
803-00-091 In distribution
804-00-037 In distribution
801-01-647 In distribution
804-25-144 In distribution
804-02-083 In distribution
804-02-084 In distribution
804-05-089 In distribution
804-25-046 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