Surfix®
The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the screw and to screw screws and lock screws. It is also used to remove screws and lock screws.
18manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | 2023-02-06 (version 5) |
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 |
|---|---|---|
| 219835ND | 2.0mm diam. x 180mm total length | In distribution |
| 219135ND | T10 Torx; 2.5mm diameter 180mm total length | In distribution |
| 219465ND | 3.49mm diam. x 76mm total length | In distribution |
| 219865ND | 3.49mm 6 pans; 215mm total length | In distribution |
| 219227ND | T7 Torx; 2mm diameter X 100mm total length | In distribution |
| 219127ND | T7 Torx; 2mm diameter X 160mm total length | In distribution |
| MA004ND | 3.49mm 6 pans; 215mm total length | In distribution |
| 219845ND | 2.5mm diam. x 180mm total length | In distribution |
| 219435ND | 2.0mm diam. x 76mm total length | In distribution |
| 219445ND | 2.5mm diam. x 76mm total length | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | UDI-DI | 2022-01-04 | Class II | Process control | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | 8 units (US) |
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.