DePuy Actis DuoFix Hip Prosthesis— 510(k) K160907

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K160907 for DePuy Actis DuoFix Hip Prosthesis, Substantially Equivalent on 2016-07-19. Applicant: Depuy(Ireland).

Clearance details

Applicant: Depuy(Ireland)
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2016-04-01
Decision date: 2016-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.