FuzeFix Max FT
Chamfered Screw Long Drill 4.0mm (3.2mm) (Sterile)
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| 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-1840 | In distribution | |
| CD-CS-1840-S | In distribution | |
| CD-CS-1835 | In distribution | |
| CD-CS-1835-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
Showing 12 of 265. All products under Drill, Bone, Powered
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.