MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS— 510(k) K040128

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K040128 for MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS, Substantially Equivalent on 2004-03-26. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2004-01-21
Decision date: 2004-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, 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, 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.