510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020069Substantially Equivalent

Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System

Medtronic Midas Rex, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020069 is the FDA 510(k) clearance record for MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM, a class II device, cleared for Medtronic Midas Rex on under FDA product code HBB (Motor, Drill, Pneumatic). FDA records list one 510(k) clearance for Medtronic Midas Rex. As of , FDA records show 9 recalls naming K020069.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HBB Motor, Drill, Pneumatic
Regulation
21 CFR 882.4370
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Midas Rex 4620 N Beach St., Fort Worth TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBB

Trailing 12 months
1 clearance under product code HBB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260