SFS
2 catalogue numbers from 55-1047, listed by Orthofix US LLC, United States, under Bender. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
2catalogue 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.
| 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
| Listed by | Orthofix US LLC, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55-1047 | In distribution | |
| 55-1046 | In distribution |
Same 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 |
| Generic Surgical Instruments | CTL Medical Corporation | 24 |
| Specials | Seaspine Orthopedics Corporation | 24 |
| Tecomet | Tecomet, Inc. | 22 |
| Level ONE | KLS-Martin L.P. | 22 |
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.