DeviceClearance

K112059

Substantially Equivalent

T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP

Applicant
Stryker
Product code
HSB
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 HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

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.