Gsource
K-Wire S. Trocar 25mm Thr. 5" 1.6mm [.062"] pkg/6
9manufacturers in China registered for this device type
74catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K100736 |
| Record published | 2021-07-27 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| gS 78.3080 | In distribution | ||
| gS 78.8590 | In distribution | ||
| gS 78.8150 | In distribution | ||
| gS 78.5824 | In distribution | ||
| gS 78.4110 | In distribution | ||
| gS 78.8620 | In distribution | ||
| gS 78.3090 | In distribution | ||
| gS 78.8880 | In distribution | ||
| gS 78.4035 | In distribution | ||
| gS 78.5800 | 6 | In distribution | |
| gS 78.8090 | In distribution | ||
| gS 78.8680 | 6 | In distribution | |
| gS 78.8180 | 6 | In distribution | |
| gS 78.8680 | 6 | In distribution | |
| gS 78.3090 | In distribution | ||
| gS 78.4210 | In distribution | ||
| gS 78.8850 | In distribution | ||
| gS 78.8850 | 6 | In distribution | |
| gS 78.4097 | In distribution | ||
| gS 78.8450 | In distribution | ||
| gS 78.8530 | In distribution | ||
| gS 78.8560 | 6 | In distribution | |
| gS 78.8730 | In distribution | ||
| gS 78.5920 | In distribution | ||
| gS 78.2850 | In distribution | ||
| gS 78.8560 | In distribution | ||
| gS 78.4090 | 6 | In distribution | |
| gs 78.1320 | 6 | In distribution | |
| gS 78.8700 | 6 | In distribution | |
| gS 78.8820 | In distribution | ||
| gS 78.8500 | In distribution | ||
| gS 78.8030 | In distribution | ||
| gS 78.8650 | 6 | In distribution | |
| gS 78.8420 | In distribution | ||
| gS 78.5890 | In distribution | ||
| gS 78.4030 | 6 | In distribution | |
| gS 78.8880 | 6 | In distribution | |
| gS 78.4090 | In distribution | ||
| gS 78.2820 | 6 | In distribution | |
| gS 78.2850 | In distribution | ||
| gS 78.8760 | In distribution | ||
| gS 78.8000 | 6 | In distribution | |
| gS 78.4080 | In distribution | ||
| gS 78.8360 | 6 | In distribution | |
| gS 78.8060 | 6 | In distribution | |
| gS 78.9112 | 6 | In distribution | |
| gS 78.8120 | In distribution | ||
| gS 78.8650 | In distribution | ||
| gS 78.8780 | In distribution | ||
| gS 78.5860 | In distribution | ||
| gS 78.8180 | In distribution | ||
| gS 78.8390 | In distribution | ||
| gS 78.5830 | In distribution | ||
| gS 78.4220 | In distribution | ||
| gS 78.8060 | In distribution | ||
| gS 78.8000 | In distribution | ||
| gS 78.4100 | In distribution | ||
| gS 78.8500 | 6 | In distribution | |
| gS 78.8530 | 6 | In distribution | |
| gS 78.3070 | 6 | In distribution | |
| gS 78.4085 | In distribution | ||
| gS 78.4230 | In distribution | ||
| gS 78.5820 | In distribution | ||
| gS 78.5800 | In distribution | ||
| gS 78.8780 | 6 | In distribution | |
| gS 78.8360 | In distribution | ||
| gS 78.5890 | 6 | In distribution | |
| gS 78.8730 | 6 | In distribution | |
| gS 78.8700 | In distribution | ||
| gS 78.8150 | 6 | In distribution | |
| gS 78.3070 | In distribution | ||
| gS 78.4030 | In distribution | ||
| gS 78.3080 | In distribution | ||
| gS 78.2840 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
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.