METHA SHORT STEM HIP SYSTEM— 510(k) K080584

Name: FDA 510(k) clearance K080584
Creator: U.S. Food and Drug Administration
Published: 2008-05-09

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K080584 for METHA SHORT STEM HIP SYSTEM, Substantially Equivalent on 2008-05-09. Applicant: Aesculap Implant System, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2008-03-03
Decision date: 2008-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, 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.