SHORT CITATION FEMORAL STEM— 510(k) K053528

Name: FDA 510(k) clearance K053528
Creator: U.S. Food and Drug Administration
Published: 2006-01-13

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K053528 for SHORT CITATION FEMORAL STEM, Substantially Equivalent on 2006-01-13. Applicant: Stryker Orthopaedics. Device class: 2.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2005-12-19
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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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.