Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
FDA 510(k) K213454 · Medtronic Powered Surgical Solutions
510(k) numberK213454
Submission
- Device name
- Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
- Applicant
- Medtronic Powered Surgical Solutions
Fort Worth, TX, US - Received
- October 26, 2021
- Decision date
- November 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional | Surgify Medical OY | 03/26/2026SE |
| K250815 | Hubly Drill (H100)HBE · Traditional | Hubly, Inc. | 11/06/2025SE |
| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
| K252662 | UniBurHBE · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 06/04/2025SE |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 03/13/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | Stryker Instruments | 03/11/2025SE |
| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | Biomet Microfixation | 11/15/2022SE |
More from Biomet Microfixation
| 510(k) | Device | Decision |
|---|---|---|
| K183644 | Stealth-Midas MR8 SystemOLO · Traditional | 05/22/2019SE |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView ToolsHBC · Traditional | 05/12/2019SE |
| 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 Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm cleared by the FDA?
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm (K213454) received a 510(k) decision of Substantially Equivalent on November 23, 2021, 28 days after the submission was received.
What is the product code of K213454?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.