DeviceClearance

K163182

Substantially Equivalent

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

Applicant
Medtronic Powered Surgical Solutions
Product code
HBB
Advisory panel
Neurology
Date received
Decision date
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, through . 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.