Dynafix VS Osteotomy System
21 catalogue numbers from 13175P, listed by Biomet Orthopedics, United States, under Plate, Fixation, Bone, Non-Spinal, Metallic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 | NDF |
| Device type | Plate, Fixation, Bone, Non-Spinal, 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 |
|---|---|---|
| 13175P | 17.5 MM 6 HOLE | In distribution |
| 14070P | 6.0MM Ø 70MM LENGTH | In distribution |
| 14045P | 6.0MM Ø 45MM LENGTH | In distribution |
| 11050P | 5.0 MM 4 HOLE | In distribution |
| 10062P | 6.25 MM 4 HOLE | In distribution |
| 11062P | 6.25 MM 4 HOLE | In distribution |
| 13200P | 20.0 MM 6 HOLE | In distribution |
| 12225P | 22.5 MM 6 HOLE | In distribution |
| 11100P | 10.0 MM 4 HOLE | In distribution |
| 11088P | 8.75 MM 4 HOLE | In distribution |
| 14050P | 6.0MM Ø 50MM LENGTH | In distribution |
| 12200P | 20.0 MM 6 HOLE | In distribution |
| 14075P | 6.0MM Ø 75MM LENGTH | In distribution |
| 11125P | 12.5 MM 4 HOLE | In distribution |
| 14044P | 6.0MM Ø 44MM LENGTH | In distribution |
| 10075P | 7.5 MM 4 HOLE | In distribution |
| 10125P | 12.5 MM 4 HOLE | In distribution |
| 13225P | 22.5 MM 6 HOLE | In distribution |
| 10088P | 8.75 MM 4 HOLE | In distribution |
| 14055P | 6.0MM Ø 55MM LENGTH | In distribution |
| 14065P | 6.0MM Ø 65MM LENGTH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PolyLock SmallBone | Fusion Orthopedics, LLC | 1 |
| VS Osteotomy System | Biomet Orthopedics | 1 |
| PolyLock Small Bone | 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.