Plasmafit
Articulated Screw Driver SW3,5
18manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | HXX |
| Device type | Screwdriver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-24 |
| Record revised | 2023-05-03 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NT428R | In distribution | |
| NT412R | 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
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 |
|---|---|---|---|---|---|
| 2021-10-25 | Class II | Component design/selection | Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant. | 9 pieces | 2024-06-12 |
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.