SSG10
Traus SSG10 is an electrical appliance intended for cutting, shaving, bone and tissue resection, grinding and drilling in the cranium and spine. The filing excludes its shaver handpiece…
Traus SSG10 is an electrical appliance intended for cutting, shaving, bone and tissue resection, grinding and drilling in the cranium and spine. The filing excludes its shaver handpiece from neurosurgical procedures.
The subject filing describes a console-type appliance that connects with handpieces. Its listed system components include a control box, micro motor and foot controller.
Listed Item
BSG10/FUS12/MBP20SX/MBP20SX/TST20NN04/TST20NN04/TST20NN04/TST20NN04
System Components
The comparison table lists a console with foot pedal and identifies drill, saw and shaver functions for the SSG10 system. It also lists digital speed indication.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
Record
| Listed by | Saeshin Precision Co., Ltd., South Korea |
|---|---|
| FDA product code | HBC |
| Device type | Motor, Drill, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4360 |
| Establishment | Manufacturer |
| 510(k) | K233153 |
| Record published | 2025-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSG10 #7 | In distribution | |
| SSG10 #4 | In distribution | |
| SSG10 #9 | In distribution | |
| SSG10 #1 | In distribution | |
| SSG10 #11 | In distribution | |
| SSG10 #3 | In distribution | |
| SSG10 #10 | In distribution | |
| SSG10 #5 | In distribution | |
| SSG10 | In distribution | |
| SSG10 #2 | In distribution | |
| SSG10 #6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NSK Sterile Burs/Drills | Nakanishi Inc. | 447 |
| Motor, Drill, Electric | Anspach Effort, The | 168 |
| Primado2 | Nakanishi Inc. | 96 |
| Elan 4 | Aesculap AG | 39 |
| Midas REX® | Medtronic Powered Surgical Solutions | 29 |
| NSK Sterile Blades | Nakanishi Inc. | 24 |
| Motor, Drill, Electric | Synthes Gmbh | 22 |
| Aesculap | Aesculap AG | 14 |
| Traus | Saeshin Precision Co., Ltd. | 9 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 7 |
| Eccos | Aesculap AG | 7 |
| Motor, Drill, Electric | Medtronic Xomed, Inc. | 6 |
Showing 12 of 75. All products under Motor, Drill, Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233153 | 2024-09-20 |
| K232938 | 2024-09-16 |
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.