Home / 510(k) Clearances / K183515

510(k) K183515

MR8 Drill System, Midas Rex MR8 ClearView Tools by Medtronic Powered Surgical Solutions — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2019
Date Received
December 18, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

Other clearances by Medtronic Powered Surgical Solutions

  • K213454 — Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas (November 23, 2021)
  • K183644 — Stealth-Midas MR8 System (May 22, 2019)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 2017)
  • K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpo (March 23, 2017)
  • K160713 — Stealth-Midas System (May 26, 2016)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K072315 — MIDAS REX CURVED BUR (September 18, 2007)

Other clearances for product code HBC

  • K233153 — Traus SSG10 Surgical System (September 20, 2024)
  • K232938 — Traus SSG30 Surgical System (September 16, 2024)
  • K213697 — ORiGO System (October 31, 2022)
  • K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E (May 19, 2022)
  • K193630 — hekaDrill (April 9, 2021)
  • K173066 — OSSEODUO Shaver and Drill System (June 22, 2018)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 2017)
  • K152960 — ELAN 4 Motor System (July 22, 2016)
  • K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (January 10, 2014)