MIDAS REX CURVED BUR— 510(k) K072315

Substantially Equivalent

Medtronic Powered Surgical Solutions

FDA 510(k) clearance K072315 for MIDAS REX CURVED BUR, Substantially Equivalent on 2007-09-18. Applicant: Medtronic Powered Surgical Solutions.

Clearance details

Applicant: Medtronic Powered Surgical Solutions
Product code: Code HBE
Advisory panel: Neurology
Date received: 2007-08-20
Decision date: 2007-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.