VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS— 510(k) K092265

Name: FDA 510(k) clearance K092265
Creator: U.S. Food and Drug Administration
Published: 2010-03-12

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K092265 for VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS, Substantially Equivalent on 2010-03-12. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2009-07-29
Decision date: 2010-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.