FDA 510(k) Applications Submitted by MEDTRONIC POWERED SURGICAL SOLUTIONS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K213454 |
10/26/2021 |
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 |
Medtronic Powered Surgical Solutions |
| K170312 |
02/01/2017 |
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
| K160713 |
03/15/2016 |
Stealth-Midas System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
| K163182 |
11/14/2016 |
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories |
Medtronic Powered Surgical Solutions |
| K163565 |
12/19/2016 |
MR8 Drill System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
| K090112 |
01/16/2009 |
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
| K072315 |
08/20/2007 |
MIDAS REX CURVED BUR |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
| K183515 |
12/18/2018 |
MR8 Drill System, Midas Rex MR8 ClearView Tools |
Medtronic Powered Surgical Solutions |
| K183644 |
12/26/2018 |
Stealth-Midas MR8 System |
Medtronic Powered Surgical Solutions |
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