MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k) K183515 · Medtronic Powered Surgical Solutions
510(k) numberK183515
Submission
- Device name
- MR8 Drill System, Midas Rex MR8 ClearView Tools
- Applicant
- Medtronic Powered Surgical Solutions
Fort Worth, TX, US - Received
- December 18, 2018
- Decision date
- May 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…HBC · Traditional | The Anspach Effort, Inc. | 05/19/2022SE |
| K193630 | hekaDrillHBC · Traditional | Zethon, Ltd. | 04/09/2021SE |
| 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 |
|---|---|---|
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…HBE · Special | 11/23/2021SE |
| K183644 | Stealth-Midas MR8 SystemOLO · Traditional | 05/22/2019SE |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…HBC · Traditional | 05/15/2017SE |
| K163565 | MR8 Drill SystemHBC · Traditional | 03/28/2017SE |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…HBB · Traditional | 03/23/2017SE |
| K160713 | Stealth-Midas SystemOLO · Traditional | 05/26/2016SE |
| K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700HBB · Traditional | 03/26/2009SE |
| K072315 | Midas Rex Curved BurHBE · Special | 09/18/2007SE |
Questions and answers
When was MR8 Drill System, Midas Rex MR8 ClearView Tools cleared by the FDA?
MR8 Drill System, Midas Rex MR8 ClearView Tools (K183515) received a 510(k) decision of Substantially Equivalent on May 12, 2019, 145 days after the submission was received.
What is the product code of K183515?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.