Company ยท US
Medtronic Powered Surgical Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2021. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2021 | K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex Medtronic Powered Surgical Solutions | HBE |
| May 22, 2019 | K183644 | Stealth-Midas MR8 System Medtronic Powered Surgical Solutions | OLO |
| May 12, 2019 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools Medtronic Powered Surgical Solutions | HBC |
| May 15, 2017 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque ha Medtronic Powered Surgical Solutions | HBC |
| Mar 28, 2017 | K163565 | MR8 Drill System Medtronic Powered Surgical Solutions | HBC |
| Mar 23, 2017 | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Att Medtronic Powered Surgical Solutions | HBB |
| May 26, 2016 | K160713 | Stealth-Midas System Medtronic Powered Surgical Solutions | OLO |
| Mar 26, 2009 | K090112 | MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700 Medtronic Powered Surgical Solutions | HBB |
| Sep 18, 2007 | K072315 | MIDAS REX CURVED BUR Medtronic Powered Surgical Solutions | HBE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2008 | Medtronic Powered Surgical Solutions Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23
Medtronic Powered Surgical Solutions, Forth Worth, TX
Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Terminated |
HBB | K020069 |
| Aug 3, 2005 | Medtronic Powered Surgical Solutions Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137. Terminated |
HBB | K020069 |