Flow-Screw™
FN Jig retention bolt
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Flow-Fx, LLC, United States |
|---|---|
| FDA product code | NDH |
| Device type | Nail, Fixation, Bone, Metallic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K140601 |
| Record published | 2020-12-18 |
| Record revised | 2025-07-14 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dynafix VS Osteotomy System | Biomet Orthopedics | 22 |
| Flow-Nail™ | Flow-Fx, LLC | 6 |
| VS Osteotomy System | Biomet Orthopedics | 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.