ESOP S/C FEMORAL STEM— 510(k) K964878

Name: FDA 510(k) clearance K964878
Creator: U.S. Food and Drug Administration
Published: 1998-03-05

Substantially Equivalent for Some Indications

Fournitures Hospitalieres

FDA 510(k) clearance K964878 for ESOP S/C FEMORAL STEM, Substantially Equivalent for Some Indications on 1998-03-05. Applicant: Fournitures Hospitalieres. Device class: 2.

Clearance details

Applicant: Fournitures Hospitalieres
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1996-12-05
Decision date: 1998-03-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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K021109 — ESOP CO-CR FEMORAL HEADS2002-06-12
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K961388 — ATLAS III ACETABULAR CUP1997-04-03

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.