DeviceClearance

K081278

Substantially Equivalent

OMEGA 3 TROCHANTERIC STABILIZING PLATE

Applicant
Howmedica Osteonics Corp.
Product code
KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mahwah, NJ, 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.