DeviceClearance

K072578

Substantially Equivalent

SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM

Applicant
Synthes (Usa)
Product code
HSD
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 HSD

product code HSD
Injury
3,425
Malfunction
531
Total
3,956

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.