Smtp
Unilateral hook-shaped scalpel with serrations(80mm)
6manufacturers in China registered for this device type
48catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Smtp Medical Co., Ltd. | Daxing District | Beijing | Manufacturer | 2 |
| Huaan Hengyi (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Shenzhen Codyson Electrical Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Smtp Medical Co., Ltd., China |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| Establishment | Manufacturer, Exporter |
| Record published | 2023-08-15 |
| Record revised | 2025-11-24 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XDF07801N | In distribution | |
| XDF02801521 | In distribution | |
| XDF02812563 | In distribution | |
| XDF09801 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02812560 | In distribution | |
| XDF07801 | In distribution | |
| XDF03801 | In distribution | |
| XDF02801529 | In distribution | |
| XDF02806518 | In distribution | |
| XDF01838 | In distribution | |
| XDF02806523 | In distribution | |
| XDF02801522 | In distribution | |
| XDF02806523 | In distribution | |
| XDF02812532 | In distribution | |
| XDF02812532 | In distribution | |
| XDF02806525 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02812533 | In distribution | |
| XDF06801 | In distribution | |
| XDF02801528 | In distribution | |
| XDF02806552 | In distribution | |
| XDF0980115 | In distribution | |
| XDF02806517 | In distribution | |
| XDF02801521 | In distribution | |
| XDF02806523 | In distribution | |
| XDF02801537 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02801520 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02801521 | In distribution | |
| XDF02801537 | In distribution | |
| XDF02806518 | In distribution | |
| XDF02812532 | In distribution | |
| XDF02801521 | In distribution | |
| XDF02812565 | In distribution | |
| XDF02806525 | In distribution | |
| XDF02801521 | In distribution | |
| XDF02801521 | In distribution | |
| XDF05802 | In distribution | |
| XDF02801521 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02801528 | In distribution | |
| XD880A | In distribution | |
| XDF02806518 | In distribution | |
| XDF02806510C | In distribution | |
| XDF02806513 | In distribution | |
| XDF09801 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Satelec | 95 |
| Tors | Radley Scientific Ltd | 76 |
| Oscar PRO | Orthofix SRL | 36 |
| Ultra-Drive® Tool | Biomet Orthopedics | 11 |
| Mectron | Mectron SPA | 11 |
| Oscar | Orthosonics, Ltd. | 2 |
| Satelec | Satelec | 1 |
| Ultra-Drive® | Biomet Orthopedics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201274 | 2021-02-19 |
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.