DeviceClearance

K111437

Substantially Equivalent

SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)

Applicant
Synthes (USA) Products, LLC
Product code
HTO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Chester, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HTO

product code HTO
Injury
404
Malfunction
20,305
Total
20,709

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.