Arthrex®
Low Profile Screw, Cortical,3.5x15mm,DRP
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 | Arthrex, Inc., United States |
|---|---|
| FDA product code | HSR |
| Device type | Unit, Traction, Hip, Non-Powered, Non-Penetrating |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2023-05-25 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-8735-15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fine Osteotomy implants – Distal femur | Laboratoires Bodycad, 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.