K-Wire With Stop 1.0mm
2 catalogue numbers from 22794, listed by Biopro, Inc., United States, under Wire, Surgical. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Biopro, Inc., United States |
|---|---|
| FDA product code | LRN |
| Device type | Wire, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K162674 |
| Record published | 2020-08-05 |
| Record revised | 2024-02-19 (version 4) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22794 | In distribution | |
| 20666 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wire, Surgical | Synthes Gmbh | 22 |
| GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC. | 12 |
| Atlas® Cable System | Medtronic Sofamor Danek, Inc. | 11 |
| Dall-Miles | Howmedica Osteonics Corp | 7 |
| LapiLock | Fusion Orthopedics, LLC | 6 |
| FibFix | Fusion Orthopedics, LLC | 5 |
| FuzeFix Max FT | Fusion Orthopedics, LLC | 3 |
| Wire, Surgical | Depuy Intl., Ltd. | 1 |
| Control | Depuy Orthopaedics, Inc. | 1 |
| FuzeRight | Fusion Orthopedics, LLC | 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.