DeviceClearance

K142052

Substantially Equivalent

ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT

Applicant
Orthofix Srl
Product code
KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, NC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.