Bender
Coronal Bender/Global Inner Right FOR 5.5MM Rods
10manufacturers in China registered for this device type
48catalogue numbers in this listing
1recall
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HXW |
| Device type | Bender |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2025-10-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SD03.632.044 | In distribution | ||
| 03.503.038 | In distribution | ||
| SD03.632.017 | In distribution | ||
| 02.600.024 | In distribution | ||
| 388.92 | In distribution | ||
| 03.501.450 | In distribution | ||
| 321.744 | In distribution | ||
| 02.600.022.10S | 10 | In distribution | |
| 03.632.039 | In distribution | ||
| 321.131 | In distribution | ||
| 03.632.038 | In distribution | ||
| 03.632.017 | In distribution | ||
| SD03.632.040 | In distribution | ||
| SD388.096 | In distribution | ||
| SD388.112 | In distribution | ||
| SD03.632.041 | In distribution | ||
| 03.221.251 | In distribution | ||
| SD03.503.035 | In distribution | ||
| 02.600.022.02S | 2 | In distribution | |
| 388.91 | In distribution | ||
| 324.065 | In distribution | ||
| 04.600.023.02S | 2 | In distribution | |
| 03.600.004 | In distribution | ||
| 388.96 | In distribution | ||
| SD388.090 | In distribution | ||
| 03.161.042 | In distribution | ||
| 03.503.030 | In distribution | ||
| 02.600.026 | In distribution | ||
| 03.501.449 | In distribution | ||
| 02.600.022 | In distribution | ||
| 387.293 | In distribution | ||
| SD03.632.042 | In distribution | ||
| SD388.113 | In distribution | ||
| 04.600.023.10S | 10 | In distribution | |
| 04.600.029.02S | 2 | In distribution | |
| 04.600.022.10S | 10 | In distribution | |
| SD03.632.043 | In distribution | ||
| SD314.013 | In distribution | ||
| 02.600.028 | In distribution | ||
| SD314.012 | In distribution | ||
| 03.632.041 | In distribution | ||
| 04.600.029.10S | 10 | In distribution | |
| 03.632.040 | In distribution | ||
| 04.600.022.02S | 2 | In distribution | |
| 03.614.022 | In distribution | ||
| 03.503.031 | In distribution | ||
| 388.961 | In distribution | ||
| 03.161.057 | 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 |
| 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 |
| Orthomed | Ortho-MED, Inc. | 21 |
Showing 12 of 279. All products under Bender
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-12-15 | Class II | Finished device change control | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located. | 973 | 2016-08-18 |
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.