Dynafix VS Osteotomy System
22 catalogue numbers from 13150P, listed by Biomet Orthopedics, United States, under Nail, Fixation, Bone, Metallic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
22catalogue numbers in this listing
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | NDH |
| Device type | Nail, Fixation, Bone, Metallic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K010551 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13150P | 15.0 MM 6 HOLE | In distribution |
| 14090P | 6.0MM Ø 90MM LENGTH | In distribution |
| 11112P | 11.25 MM 4 HOLE | In distribution |
| 14024P | 6.0MM Ø 24MM LENGTH | In distribution |
| 14032P | 6.0MM Ø 32MM LENGTH | In distribution |
| 10112P | 11.25 MM 4 HOLE | In distribution |
| 14080P | 6.0MM Ø 80MM LENGTH | In distribution |
| 14040P | 6.0MM Ø 40MM LENGTH | In distribution |
| 14028P | 6.0MM Ø 28MM LENGTH | In distribution |
| 14042P | 6.0MM Ø 42MM LENGTH | In distribution |
| 14034P | 6.0MM Ø 34MM LENGTH | In distribution |
| 14030P | 6.0MM Ø 30MM LENGTH | In distribution |
| 14085P | 6.0MM Ø 85MM LENGTH | In distribution |
| 14038P | 6.0MM Ø 38MM LENGTH | In distribution |
| 11075P | 7.5 MM 4 HOLE | In distribution |
| 12175P | 17.5 MM 6 HOLE | In distribution |
| 12150P | 15.0 MM 6 HOLE | In distribution |
| 14060P | 6.0MM Ø 60MM LENGTH | In distribution |
| 14036P | 6.0MM Ø 36MM LENGTH | In distribution |
| 14026P | 6.0MM Ø 26MM LENGTH | In distribution |
| 10100P | 10.0 MM 4 HOLE | In distribution |
| 10050P | 5.0 MM 4 HOLE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flow-Nail™ | Flow-Fx, LLC | 6 |
| VS Osteotomy System | Biomet Orthopedics | 1 |
| Flow-Screw™ | Flow-Fx, 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.