Gsource
K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1
12manufacturers in China registered for this device type
221catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| 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 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K100736 |
| Record published | 2021-07-19 |
| Record revised | 2024-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| gS 78.6130 | In distribution | ||
| gS 78.2750 | 6 | In distribution | |
| gS 78.5560 | In distribution | ||
| gS 78.2060 | 6 | In distribution | |
| gS 78.8480 | In distribution | ||
| gS 78.3342 | In distribution | ||
| gS 78.7060 | In distribution | ||
| gS 78.3110 | 6 | In distribution | |
| gS 78.5950 | In distribution | ||
| gS 78.2240 | 6 | In distribution | |
| gS 78.2220 | 6 | In distribution | |
| gS 79.2316 | In distribution | ||
| gS 78.1340 | 6 | In distribution | |
| gS 79.2003 | In distribution | ||
| gS 78.7630 | 6 | In distribution | |
| gS 78.3350 | In distribution | ||
| gS 78.7660 | 6 | In distribution | |
| gS 78.1330 | 6 | In distribution | |
| gS 78.5650 | In distribution | ||
| gS 78.3100 | In distribution | ||
| gS 78.7940 | 6 | In distribution | |
| gS 79.2006 | In distribution | ||
| gS 78.7120 | In distribution | ||
| gS 78.3360 | In distribution | ||
| gS 79.2002 | In distribution | ||
| gS 78.2700 | 6 | In distribution | |
| gS 78.7000 | 6 | In distribution | |
| gS 78.7090 | In distribution | ||
| gS 78.5620 | 6 | In distribution | |
| gS 78.3400 | In distribution | ||
| gS 79.2312 | In distribution | ||
| gS 78.8330 | In distribution | ||
| gS 78.7750 | In distribution | ||
| gS 78.3346 | 6 | In distribution | |
| gS 79.2310 | In distribution | ||
| gS 78.7150 | In distribution | ||
| gS 78.2800 | 6 | In distribution | |
| gS 78.3340 | In distribution | ||
| gS 78.2740 | 6 | In distribution | |
| gS 78.7660 | In distribution | ||
| gS 78.3320 | In distribution | ||
| gS 78.2230 | In distribution | ||
| gS 78.6250 | 6 | In distribution | |
| gS 78.7060 | 6 | In distribution | |
| gS 78.2020 | 6 | In distribution | |
| gS 79.2004 | In distribution | ||
| gS 78.1230 | 6 | In distribution | |
| gS 78.2080 | 6 | In distribution | |
| gS 78.5650 | 6 | In distribution | |
| gS 78.3310 | 6 | In distribution | |
| gS 79.2007 | In distribution | ||
| gS 78.2120 | 6 | In distribution | |
| gS 78.6250 | In distribution | ||
| gS 78.2070 | 6 | In distribution | |
| gS 78.3530 | 6 | In distribution | |
| gS 78.2600 | 6 | In distribution | |
| gS 78.2720 | 6 | In distribution | |
| gS 78.1240 | 6 | In distribution | |
| gS 78.2530 | 6 | In distribution | |
| gS 78.3344 | In distribution | ||
| gS 78.3400 | In distribution | ||
| gS 78.6160 | 6 | In distribution | |
| gS 78.3320 | In distribution | ||
| gS 78.7000 | In distribution | ||
| gS 78.3510 | In distribution | ||
| gS 78.7030 | 6 | In distribution | |
| gS 78.3348 | 6 | In distribution | |
| gS 78.3344 | In distribution | ||
| gS 78.7150 | 6 | In distribution | |
| gS 78.5620 | In distribution | ||
| gS 78.7800 | 6 | In distribution | |
| gS 78.3130 | 6 | In distribution | |
| gS 78.3030 | In distribution | ||
| gS 78.2300 | 6 | In distribution | |
| gS 78.3130 | 6 | In distribution | |
| gS 78.3000 | 6 | In distribution | |
| gS 79.2116 | In distribution | ||
| gS 78.1220 | 6 | In distribution | |
| gS 79.2112 | In distribution | ||
| gS 78.7800 | In distribution | ||
| gS 78.1310 | 6 | In distribution | |
| gS 78.7780 | 6 | In distribution | |
| gS 78.3346 | In distribution | ||
| gS 78.1210 | 6 | In distribution | |
| gS 78.2340 | 6 | In distribution | |
| gS 78.3120 | In distribution | ||
| gS 78.3420 | 6 | In distribution | |
| gS 78.5720 | In distribution | ||
| gS 78.2860 | 6 | In distribution | |
| gS 78.5980 | 6 | In distribution | |
| gS 78.2540 | 6 | In distribution | |
| gS 78.7120 | 6 | In distribution | |
| gS 78.3050 | In distribution | ||
| gS 78.3420 | In distribution | ||
| gS 78.2640 | In distribution | ||
| gS 78.7780 | In distribution | ||
| gS 78.5680 | In distribution | ||
| gS 78.6160 | In distribution | ||
| gS 78.2330 | 6 | In distribution | |
| gS 78.5680 | 6 | In distribution | |
| gS 78.3341 | In distribution | ||
| gS 78.1300 | In distribution | ||
| gS 79.2315 | In distribution | ||
| gS 78.2010 | 6 | In distribution | |
| gS 78.2810 | 6 | In distribution | |
| gS 78.2210 | 6 | In distribution | |
| gS 79.2115 | In distribution | ||
| gS 79.2005 | In distribution | ||
| gS 79.2110 | In distribution | ||
| gS 78.3230 | 6 | In distribution | |
| gS 79.2009 | In distribution | ||
| gS 78.3300 | 6 | In distribution | |
| gS 78.1250 | 6 | In distribution | |
| gS 79.2315 | In distribution | ||
| gS 79.2118 | In distribution | ||
| gS 78.3220 | In distribution | ||
| gS 78.6280 | In distribution | ||
| gS 78.2130 | 6 | In distribution | |
| gS 78.7180 | 6 | In distribution | |
| gS 78.3380 | In distribution | ||
| gS 78.2310 | 6 | In distribution | |
| gS 79.2008 | In distribution | ||
| gS 78.2320 | 6 | In distribution | |
| gS 78.2520 | 6 | In distribution | |
| gS 78.2040 | 6 | In distribution | |
| gS 78.7690 | 6 | In distribution | |
| gS 79.2106 | In distribution | ||
| gS 78.3100 | 6 | In distribution | |
| gS 78.3410 | In distribution | ||
| gS 78.7030 | In distribution | ||
| gS 78.3210 | In distribution | ||
| gS 78.3060 | 6 | In distribution | |
| gS 78.5500 | In distribution | ||
| gS 79.2118 | In distribution | ||
| gS 78.3410 | 6 | In distribution | |
| gS 79.2312 | In distribution | ||
| gS 79.2115 | In distribution | ||
| gS 78.6190 | 6 | In distribution | |
| gS 78.7750 | 6 | In distribution | |
| gS 78.7782 | 6 | In distribution | |
| gS 78.3140 | In distribution | ||
| gS 78.3342 | In distribution | ||
| gS 78.5698 | In distribution | ||
| gS 78.7180 | In distribution | ||
| gS 78.7630 | In distribution | ||
| gS 78.3140 | In distribution | ||
| gS 78.2000 | 6 | In distribution | |
| gS 78.3430 | 6 | In distribution | |
| gS 78.3040 | 6 | In distribution | |
| gS 79.2306 | In distribution | ||
| gS 78.3370 | In distribution | ||
| gS 78.5950 | 6 | In distribution | |
| gS 78.3120 | 6 | In distribution | |
| gS 78.5590 | In distribution | ||
| gS 78.3210 | In distribution | ||
| gS 78.6288 | In distribution | ||
| gS 78.2860 | In distribution | ||
| gS 78.3390 | 6 | In distribution | |
| gS 78.5530 | 6 | In distribution | |
| gS 78.3020 | 6 | In distribution | |
| gS 78.6280 | 6 | In distribution | |
| gS 78.8300 | 6 | In distribution | |
| gS 79.2106 | In distribution | ||
| gS 78.8300 | In distribution | ||
| gS 78.3340 | In distribution | ||
| gS 79.2110 | In distribution | ||
| gS 78.2620 | 6 | In distribution | |
| gS 78.3341 | In distribution | ||
| gS 78.6130 | 6 | In distribution | |
| gS 78.5590 | 6 | In distribution | |
| gS 78.3240 | In distribution | ||
| gS 79.2306 | In distribution | ||
| gS 78.7690 | In distribution | ||
| gS 79.2015 | In distribution | ||
| gS 78.5920 | 6 | In distribution | |
| gS 78.3300 | In distribution | ||
| gS 78.3010 | 6 | In distribution | |
| gS 78.5530 | In distribution | ||
| gS 78.2610 | 6 | In distribution | |
| gS 79.2310 | In distribution | ||
| gS 78.2510 | 6 | In distribution | |
| gS 78.3320 | In distribution | ||
| gS 78.5500 | 6 | In distribution | |
| gS 78.6100 | 6 | In distribution | |
| gS 78.2090 | 6 | In distribution | |
| gS 78.6100 | In distribution | ||
| gS 79.2112 | In distribution | ||
| gS 78.2105 | 6 | In distribution | |
| gS 78.3200 | In distribution | ||
| gS 78.3530 | In distribution | ||
| gS 78.2630 | 6 | In distribution | |
| gS 78.2500 | 6 | In distribution | |
| gS 78.2140 | 6 | In distribution | |
| gS 78.8480 | 6 | In distribution | |
| gS 78.2710 | 6 | In distribution | |
| gS 79.2116 | In distribution | ||
| gS 78.3525 | In distribution | ||
| gS 78.2110 | 6 | In distribution | |
| gS 79.2010 | In distribution | ||
| gS 78.3130 | In distribution | ||
| gS 78.3500 | In distribution | ||
| gS 78.7940 | In distribution | ||
| gS 78.6190 | In distribution | ||
| gS 78.5980 | In distribution | ||
| gS 78.3330 | In distribution | ||
| gS 79.2318 | In distribution | ||
| gS 78.3220 | In distribution | ||
| gS 78.5724 | In distribution | ||
| gS 78.2030 | 6 | In distribution | |
| gS 78.7720 | 6 | In distribution | |
| gS 78.3330 | In distribution | ||
| gS 78.3440 | In distribution | ||
| gS 78.3520 | In distribution | ||
| gS 78.3110 | In distribution | ||
| gS 79.2316 | In distribution | ||
| gS 78.6220 | In distribution | ||
| gS 79.2012 | In distribution | ||
| gS 78.3140 | In distribution | ||
| gS 78.7720 | In distribution | ||
| gS 78.2200 | In distribution | ||
| gS 78.2640 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
| Steinmann Pins, K-Wire, smooth | Gebr. Brasseler Gmbh & Co. KG | 110 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
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.