Medtronic Powered Surgical ... — FDA 510(k) Submissions

Medtronic Powered Surgical Solutions — FDA 510(k) Submissions

Medtronic Powered Surgical Solutions has submitted 9 FDA 510(k) premarket notifications since 2007, of which 9 received clearance as substantially equivalent to a predicate device.

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 · HBE Drills, Burrs, Trephines... · Neurology

Nov 2021 28d

Stealth-Midas MR8 System

K183644 · OLO Orthopedic Stereotaxic... · Orthopedic

May 2019 147d

MR8 Drill System, Midas Rex MR8 ClearView Tools

K183515 · HBC Motor, Drill, Electric · Neurology

May 2019 145d

IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

K170312 · HBC Motor, Drill, Electric · Neurology

May 2017 103d

MR8 Drill System

K163565 · HBC Motor, Drill, Electric · Neurology

Mar 2017 99d

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

K163182 · HBB Motor, Drill, Pneumatic · Neurology

Mar 2017 129d

Stealth-Midas System

K160713 · OLO Orthopedic Stereotaxic... · Orthopedic

May 2016 72d

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700

K090112 · HBB Motor, Drill, Pneumatic · Neurology

Mar 2009 69d

MIDAS REX CURVED BUR

K072315 · HBE Drills, Burrs, Trephines... · Neurology

Sep 2007 29d

Medtronic Powered Surgical Solutions

Medtronic Powered Surgical Solutions — FDA 510(k) Submissions

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