Midas Rex Telescoping System

• • Terminated Z-1574-05 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005

  Potential compromise of sterile packaging for disposable dissecting tools.

• • Terminated Z-0441-05 FDA Unclassified (pre-2012) ·initiated 3 Jan 2005

  Device is missing the sub-collet component within the dissecting tool package.

510(k) Number

K953433 ↗

FDA Product Code

GET

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Midas Rex Drill Attachments & Twist Drills

  Class I

  FDA 510(k) K954076 Active Cleared 18 Oct 1995

• Midas Rex Motors (Midas I, II & Convertible Models)

  Class I

  FDA 510(k) K952300 Active Cleared 26 May 1995

• Midas Rex Operating Room Vise

  Not classified

  FDA 510(k) K854123 Active Cleared 13 Nov 1985

• Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools

  Class I

  FDA 510(k) K953432 Active Cleared 14 Sep 1995

• Midas Rex Motors, (Midas I, Midas II & Convertible Models)

  Class II

  FDA 510(k) K953434 Active Cleared 16 May 1996

• Midas Rex III Motor and Attachments (Midas III)

  Class II

  FDA 510(k) K970965 Active Cleared 9 Apr 1997

See all devices from Midas Rex Pneumatic Tools, Inc. →