OrthoSolutions ‘System26’ Bone Screws
K-Wire FOR 3.0MM Screw Single Trocar 1.0 X 100MM (S/S 316 LVM)
12manufacturers in China registered for this device type
27catalogue 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 | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment |
| 510(k) | K163489 |
| Record published | 2018-09-26 |
| Record revised | 2025-06-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-04-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS900088-NS | In distribution | |
| OS900085-NS | In distribution | |
| OS900033-NS | In distribution | |
| OS900099-NS | In distribution | |
| OS900027-NS | In distribution | |
| OS900101-NS | In distribution | |
| OS900032-NS | In distribution | |
| OS900083-NS | In distribution | |
| OS900084-NS | In distribution | |
| OS900087-NS | In distribution | |
| OS900086-NS | In distribution | |
| OS900031-NS | In distribution | |
| OS900105-NS | In distribution | |
| OS900100-NS | In distribution | |
| OS900102-NS | In distribution | |
| OS900104-NS | In distribution | |
| OS900029-NS | In distribution | |
| OS900028-NS | In distribution | |
| OS900103-NS | In distribution | |
| OS900106-NS | In distribution | |
| OS900089-NS | Withdrawn | |
| OS900025-NS | Withdrawn | |
| OS900023-NS | Withdrawn | |
| OS900090-NS | Withdrawn | |
| OS900030-NS | Withdrawn | |
| OS900026-NS | Withdrawn | |
| OS900024-NS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| 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 |
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.