Acteon
Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic,…
Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic, otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, and plastic/reconstructive surgery.
6manufacturers in China registered for this device type
95catalogue 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 | Satelec, United States |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| 510(k) | K100410 |
| Record published | 2025-01-17 |
| Record revised | 2025-01-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Storage | Handling environment humidity 10 to 100 % RH; Handling environment temperature 0 to 50 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 05.001.400 | In distribution | ||
| 03.000.400.05S | 5 | In distribution | |
| LC2L M+ TIP N STER | In distribution | ||
| CS2 M+ TIP N STER | In distribution | ||
| TIP RHS6 M+ STERILE | In distribution | ||
| LC1 XL M+ TIP N STER | In distribution | ||
| RHS4R M+ N STER TIP | In distribution | ||
| 03.000.421S | In distribution | ||
| TIP BS1 XXL M+ STERILE | In distribution | ||
| TIP SL2 M+ STERILE | In distribution | ||
| BS6 XXL M+ TIP N STER | In distribution | ||
| CS6 M+ TIP N STER | In distribution | ||
| TIP RHS5 M+ STERILE | In distribution | ||
| 03.000.409S | In distribution | ||
| TIP RHS2H M+ STERILE | In distribution | ||
| CE3 II TIP N STER | In distribution | ||
| RHS BASIC M+ N STER KIT | In distribution | ||
| 03.000.410S | In distribution | ||
| TKW3 II TIP N STER | In distribution | ||
| TKW1 II TIP N STER | In distribution | ||
| SL3 M+ TIP N STER | In distribution | ||
| RHL5 M+ | In distribution | ||
| 05.001.401 | In distribution | ||
| 03.000.425S | In distribution | ||
| RHS5 M+ N STER TIP | In distribution | ||
| BS6 M+ TIP N STER | In distribution | ||
| 03.000.404S | In distribution | ||
| TKW2 II TIP N STER | In distribution | ||
| BS4 M+ TIP N STER | In distribution | ||
| 03.000.405S | In distribution | ||
| TIP BS1L M+ STERILE | In distribution | ||
| LC2R M+ TIP N STER | In distribution | ||
| TIP SL1 M+ STERILE | In distribution | ||
| 03.000.402S | In distribution | ||
| RHL4R M+ | In distribution | ||
| 03.000.419S | In distribution | ||
| TIP SL3 M+ STERILE | In distribution | ||
| BS2L M+ TIP N STER | In distribution | ||
| DB 2 M+ TIP N STER | In distribution | ||
| TIP BS1 RD M+ STERILE | In distribution | ||
| NINJA M+ TIP N STER | In distribution | ||
| 03.000.400.01S | In distribution | ||
| LC1 M+ TIP N STER | In distribution | ||
| RHS EXPERT M+ N STER KIT | In distribution | ||
| TKW5 II TIP N STER | In distribution | ||
| SL2 M+ TIP N STER | In distribution | ||
| 03.000.403S | In distribution | ||
| TIP BS6 XXL M+ STERILE | In distribution | ||
| CS5 M+ TIP N STER | In distribution | ||
| 03.000.412S | In distribution | ||
| SL5 M+ TIP N STER | In distribution | ||
| TIP RHS3R M+ STERILE | In distribution | ||
| CS4 M+ TIP N STER | In distribution | ||
| 03.000.406S | In distribution | ||
| RHS2Hb M+ N STER TIP | In distribution | ||
| RHS4L M+ N STER TIP | In distribution | ||
| 03.000.401S | In distribution | ||
| CS3 M+ TIP N STER | In distribution | ||
| CMF KIT NON-STERIL | In distribution | ||
| BS5 M+ TIP N STER | In distribution | ||
| RHS3R M+ N STER TIP | In distribution | ||
| TIP BS2L M+ STERILE | In distribution | ||
| RHL6 M+ | In distribution | ||
| RHS1 M+ N STER TIP | In distribution | ||
| SL1 M+ TIP N STER | In distribution | ||
| 03.000.408S | In distribution | ||
| RHL4L M+ | In distribution | ||
| CE2 II TIP N STER | In distribution | ||
| BS2R M+ TIP N STER | In distribution | ||
| BS1S M+ TIP N STER | In distribution | ||
| 03.000.407S | In distribution | ||
| DB 1 M+ TIP N STER | In distribution | ||
| 03.000.418S | In distribution | ||
| RHL2 | In distribution | ||
| CE1 II TIP N STER | In distribution | ||
| RHS2Fb M+ N STER TIP | In distribution | ||
| 03.000.426S | In distribution | ||
| TIP RHS2F M+ STERILE | In distribution | ||
| BS1 XXL M+ TIP N STER | In distribution | ||
| RHS6 M+ N STER TIP | In distribution | ||
| SL4 M+ TIP N STER | In distribution | ||
| BS1L M+ TIP N STER | In distribution | ||
| TKW4 II TIP N STER | In distribution | ||
| RHS3L M+ N STER TIP | In distribution | ||
| BS1 RD M+ TIP N STER | In distribution | ||
| TIP BS4 M+ STERILE | In distribution | ||
| TIP RHS3L M+ STERILE | In distribution | ||
| CS1 M+ TIP N STER | In distribution | ||
| TIP BS2R M+ STERILE | In distribution | ||
| LC2 M+ TIP N STER | In distribution | ||
| 03.000.411S | In distribution | ||
| BS2R XL M+ TIP N STER | In distribution | ||
| BS2L XL M+ TIP N STER | In distribution | ||
| 03.000.424S | In distribution | ||
| 03.000.423S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tors | Radley Scientific Ltd | 76 |
| Smtp | Smtp Medical Co., Ltd. | 48 |
| 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 |
|---|---|
| K100410 | 2010-04-28 |
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.