DeviceClearance

K901166

Substantially Equivalent

DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER

Applicant
Dalton Technology, Inc.
Product code
HXX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Glendale, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HXX

product code HXX
Injury
471
Malfunction
10,945
Total
11,416

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.