Generic Surgical Instruments

6.0 Rod Bender, In-Situ, Coronal, Right

Registry build 21.09.26
10manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HXW
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25

Record

Regulatory record for Generic Surgical Instruments
Listed by CTL Medical Corporation, United States
FDA product code HXW
Device type Bender
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-09-14
Record revised 2026-05-15 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for Generic Surgical Instruments
Catalogue number Size Status
50-4000-002 In distribution
016.7765 In distribution
015.7764 In distribution
015.7766 In distribution
100.7756 In distribution
012.7055 D4.5 In distribution
100.7766 In distribution
010.7011 In distribution
015.7062 In distribution
015.7065 In distribution
059.7763 In distribution
059.7764 In distribution
016.7766 In distribution
100.7011 In distribution
50-4000-003 In distribution
012.7054 D4.5 In distribution
100.7755 In distribution
015.7763 In distribution
011.7011 In distribution
012.7063 In distribution
100.7765 In distribution
012.7064 D3.5 In distribution
012.7065 D3.5 In distribution
015.7765 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bender Depuy Spine, Inc. 88
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 86
Invictus Alphatec Spine, Inc. 71
Bender Synthes Gmbh 48
General Instrument Orthopediatrics, Corp 32
General Instruments Alphatec Spine, Inc. 31
Surgical Instrument Jeil Medical Corporation 30
Bender Medtronic Sofamor Danek, Inc. 28
Specials Seaspine Orthopedics Corporation 24
Tecomet Tecomet, Inc. 22
Level ONE KLS-Martin L.P. 22
Orthomed Ortho-MED, Inc. 21

Showing 12 of 279. All products under Bender

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