K213454

Substantially Equivalent

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

Applicant: Medtronic Powered Surgical Solutions
Product code: HBE
Advisory panel: Neurology
Date received: 2021-10-26
Decision date: 2021-11-23
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.