ATLAS III ACETABULAR CUP— 510(k) K961388

Substantially Equivalent

Fournitures Hospitalieres

FDA 510(k) clearance K961388 for ATLAS III ACETABULAR CUP, Substantially Equivalent on 1997-04-03. Applicant: Fournitures Hospitalieres.

Clearance details

Applicant: Fournitures Hospitalieres
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1996-04-10
Decision date: 1997-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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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.