ORiGO System
FDA 510(k) K213697 · Bien-Air Surgery SA
510(k) numberK213697
Submission
- Device name
- ORiGO System
- Applicant
- Bien-Air Surgery SA
Le Noirmont, CH - Received
- November 23, 2021
- Decision date
- October 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K254174 | Surgical Power SystemHBC · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K233153 | Traus SSG10 Surgical SystemHBC · Traditional | Saeshin Precision Co., Ltd. | 09/20/2024SE |
| K232938 | Traus SSG30 Surgical SystemHBC · Traditional | Saeshin Precision Co., Ltd. | 09/16/2024SE |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…HBC · Traditional | The Anspach Effort, Inc. | 05/19/2022SE |
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| K183515 | MR8 Drill System, Midas Rex MR8 ClearView ToolsHBC · Traditional | Medtronic Powered Surgical Solutions | 05/12/2019SE |
| K173066 | OSSEODUO Shaver and Drill SystemHBC · Traditional | Bien-Air Surgery SA | 06/22/2018SE |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…HBC · Traditional | Medtronic Powered Surgical Solutions | 05/15/2017SE |
| K163565 | MR8 Drill SystemHBC · Traditional | Medtronic Powered Surgical Solutions | 03/28/2017SE |
| K152960 | ELAN 4 Motor SystemHBC · Traditional | Aesculap, Inc. | 07/22/2016SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221184 | ORiGO SystemERL · Traditional | 11/02/2022SE |
| K173066 | OSSEODUO Shaver and Drill SystemHBC · Traditional | 06/22/2018SE |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot…ERL · Traditional | 03/04/2015SE |
| K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80KERL · Traditional | 03/20/2009SE |
Questions and answers
When was ORiGO System cleared by the FDA?
ORiGO System (K213697) received a 510(k) decision of Substantially Equivalent on October 31, 2022, 342 days after the submission was received.
What is the product code of K213697?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.