Orthomed

ROD Cutter 57CM Detachable Arms Silicone Handles

Registry build 21.09.26
17manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZT
Manufacturer City Province Registered as Device types
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
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
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Taizhou Rich Medical Products Co., Ltd. Taizhou Jiangsu Contract manufacturer 20
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Ningbo Huakun Medical Equipment Co., Ltd. Cixi Zhejiang Contract manufacturer 19

Showing 12 of 17. All 17 manufacturers in China registered for Cutter, Surgical

Record

Regulatory record for Orthomed
Listed by Ortho-MED, Inc., United States
FDA product code FZT
Device type Cutter, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2026-07-15

Specifications

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

Catalogue Numbers

Catalogue numbers for Orthomed
Catalogue number Size Status
OM 69-0340 In distribution
OM 69-0341 In distribution
OM 69-0412 In distribution
OM 49-0800 In distribution
OM 69-0326 In distribution
OM 69-0445 In distribution
OM 46-0632 In distribution
OM 69-0418 In distribution
OM 46-0633 In distribution
OM 69-0320 In distribution
OM 69-0932 In distribution
OM 48-0378 In distribution
OM 69-0410 In distribution
OM 69-0344 In distribution
OM 69-0432 In distribution
OM 69-0342 In distribution
OM 69-0441 In distribution
OM 69-0440 In distribution
OM 69-0930 In distribution
OM 69-0562 In distribution
OM 69-0446 In distribution
OM 69-0297 In distribution
OM 69-0805 In distribution
OM 69-0322 In distribution
OM 46-0651 In distribution
OM 46-0626 In distribution
OM 69-0438 In distribution
OM 60-0180 In distribution
OM 69-0442 In distribution
OM 69-0343 In distribution
OM 69-0560 In distribution
OM 69-0448 In distribution
OM 46-0629 In distribution
OM 69-0327 In distribution
OM 69-0557 In distribution
OM 69-0568 In distribution
OM 69-0430 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 326
Sklar® Sklar Corporation 93
Tecomet Tecomet, Inc. 89
Timberline Lateral Fusion System Highridge Medical, LLC 46
Aesculap Aesculap AG 38
Surtex Surtex Instruments Ltd 35
SeaSpine Spacer System – Pacifica Seaspine Orthopedics Corporation 24
Millennium Avalign Technologies, Inc. 23
Cutter, Surgical Medtronic Sofamor Danek, Inc. 22
Medtronic Resuable Instruments Medtronic Sofamor Danek, Inc. 22
Velofix™ PEEK Lumbar Cage CG MedTech Co., Ltd. 20
Skyhawk Orthofix US LLC 19

Showing 12 of 177. All products under Cutter, Surgical

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