Fine Osteotomy Implants – Distal Femur
Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws
1manufacturer
1catalogue number
Who Else Makes It
Registered in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Leamai Medical Instrument Co., Ltd. | Hengshui | Hebei | Manufacturer | 5 |
Record
| Listed by | Laboratoires Bodycad, Inc. |
|---|---|
| FDA product code | HSR |
| Device type | Unit, Traction, Hip, Non-Powered, Non-Penetrating |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| 510(k) | K211646 |
| Record published | 2021-11-29 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 015-330-102 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 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.