I.co.s®
The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of…
The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 4.0mm compression screw will not be moved. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head.
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Guangdong (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 18. All 18 manufacturers in China registered for Screwdriver
Record
| Listed by | Newdeal Sas, United States |
|---|---|
| FDA product code | HXX |
| Device type | Screwdriver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-05-26 |
| Record revised | 2025-04-28 (version 6) |
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, manufacturing date |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 119561ND | 2.7mm inner/8.5mm outer diameter X 185.2mm length | In distribution |
| 119531ND | 1.75mm inner/5mm outer diameter X 184.2mm length | In distribution |
| 119536ND | 4.25mm inner/6.4mm outer diameter X 184.2mm length | Withdrawn |
| 119562ND | 2.7mm inner/8.5mm outer diameter X 110mm length | Withdrawn |
| 119532ND | 1.75mm inner/5mm outer diameter X 100mm length | Withdrawn |
| 119566ND | 6.65mm inner/10mm outer diameter X 184.7mm length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tecomet | Tecomet, Inc. | 939 |
| Screwdriver | Synthes Gmbh | 485 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 371 |
| Screwdriver | Medtronic Sofamor Danek, Inc. | 197 |
| Level ONE | KLS-Martin L.P. | 153 |
| Surgical Instrument | Jeil Medical Corporation | 116 |
| Invictus | Alphatec Spine, Inc. | 115 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 110 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 109 |
| Screwdriver | Depuy Spine, Inc. | 99 |
| Generic Surgical Instruments | CTL Medical Corporation | 93 |
| Surgical Direct | Surgical Direct, Inc. | 85 |
Showing 12 of 1,263. All products under Screwdriver
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.