MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700— 510(k) K090112

Substantially Equivalent

Medtronic Powered Surgical Solutions

FDA 510(k) clearance K090112 for MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700, Substantially Equivalent on 2009-03-26. Applicant: Medtronic Powered Surgical Solutions.

Clearance details

Applicant: Medtronic Powered Surgical Solutions
Product code: Code HBB
Advisory panel: Neurology
Date received: 2009-01-16
Decision date: 2009-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.