ACCOLADE II HIP STEM— 510(k) K120578

Substantially Equivalent

Howmedica Osteonics

FDA 510(k) clearance K120578 for ACCOLADE II HIP STEM, Substantially Equivalent on 2012-03-29. Applicant: Howmedica Osteonics.

Clearance details

Applicant: Howmedica Osteonics
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2012-02-27
Decision date: 2012-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, US

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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.