Arthrex®
M6 Ti Flange Nut, 10mm Hex, Std
3manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| YU XIN Technology(Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K190069 |
| Record published | 2026-03-13 |
| Record revised | 2026-07-27 (version 3) |
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 |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 78-10175 | In distribution | ||
| 78-10225 | In distribution | ||
| 71-10225 | In distribution | ||
| 78-6100S | In distribution | ||
| 76-10187 | In distribution | ||
| 78-20155 | In distribution | ||
| 71-00004 | 6 | In distribution | |
| 78-20001 | In distribution | ||
| 76-20209 | In distribution | ||
| 71-82000 | In distribution | ||
| 76-11165 | In distribution | ||
| 78-10135 | In distribution | ||
| 78-10155 | In distribution | ||
| 78-10195 | In distribution | ||
| 78-20215 | In distribution | ||
| 71-10215 | In distribution | ||
| 71-6140T | In distribution | ||
| 71-58215 | In distribution | ||
| 71-6140S | In distribution | ||
| 78-10215 | In distribution | ||
| 76-10201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Software For Diagnosis/Treatment | Synthes Gmbh | 108 |
| Maxframe | Synthes Gmbh | 27 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | 27 |
| Maxframe | Synthes (U.S.A.) LP | 5 |
| Acute QC Strut and Components | Smith & Nephew, Inc. | 5 |
| True Lok System | Orthofix SRL | 3 |
| Smart TSF | Smith & Nephew, Inc. | 3 |
| Orthex | Vilex IN Tennessee, Inc. | 1 |
| Enos Software Guided External Fixation System | Disior OY | 1 |
| Orthex External Fixation System | Orthopediatrics, Corp | 1 |
| Smart Correction | Wishbone Medical Inc. | 1 |
| Orthex | Orthopediatrics, Corp | 1 |
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.