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510(k) K163182

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories by Medtronic Powered Surgical Solutions — Product Code HBB

K163182 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories". The FDA issued a decision of Substantially Equivalent on March 23, 2017. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2017
Date Received
November 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
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)
  • K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools (May 12, 2019)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 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 HBB

  • K253772 — Velocity Alpha MR High Speed Surgical Drill System (March 6, 2026)
  • K172907 — ELAN 4 Air Motor System (November 9, 2018)
  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM (April 14, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041754 — STRYKER MAESTRO SYSTEM (September 7, 2004)

FDA data resources