K050637

Substantially Equivalent

ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS

Applicant: Ortho Development Corp.
Product code: JDI
Advisory panel: Orthopedic
Date received: 2005-03-11
Decision date: 2005-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.