FuzeRight
Implant Kit (Sterile)
2manufacturers in China registered for this device type
1catalogue number
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 | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | LRN |
| Device type | Wire, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K170038 |
| Record published | 2025-01-07 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FR-KW-4000-S | 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 |
| K-Wire with stop 1.0mm | Biopro, Inc. | 2 |
| Wire, Surgical | Depuy Intl., Ltd. | 1 |
| Control | Depuy Orthopaedics, Inc. | 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.