Medtronic Resuable Instruments
Bender EX0816025 IN-Situ Long Left 5.5/6
10manufacturers in China registered for this device type
19catalogue 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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HXW |
| Device type | Bender |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2022-11-14 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-11-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EX0816025 | In distribution | |
| EX0517062 | In distribution | |
| X0712086 | In distribution | |
| X0616056 | In distribution | |
| EX0915051 | In distribution | |
| EX0917001 | In distribution | |
| EX0316083 | In distribution | |
| EX0715065 | In distribution | |
| EX0915054 | In distribution | |
| EX0617035 | In distribution | |
| X0316075 | In distribution | |
| EX0517061 | In distribution | |
| EX0316075 | In distribution | |
| EX0915053 | In distribution | |
| EX0116068 | In distribution | |
| EX0516126 | In distribution | |
| EX0816026 | In distribution | |
| X0315041 | Withdrawn | |
| X0315040 | Withdrawn |
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.