FuzeFix Max FT
Chamfered Screw Jig Set Wire (Sterile)
2manufacturers in China registered for this device type
3catalogue 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 | 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 | 2025-09-17 |
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, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CD-CS-1514 | In distribution | |
| CD-CS-0950-S | In distribution | |
| CD-CS-0950 | 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 |
| K-Wire with stop 1.0mm | Biopro, Inc. | 2 |
| 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.