510(k) K080885— MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION

Substantially Equivalent

Medacta International S.A.

Clearance details

Applicant: Medacta International S.A.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2008-03-31
Decision date: 2008-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.