SMARTMIX PRE-FILLED MIXING SYSTEM— 510(k) K042591

Name: FDA 510(k) clearance K042591
Creator: U.S. Food and Drug Administration
Published: 2004-10-22

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K042591 for SMARTMIX PRE-FILLED MIXING SYSTEM, Substantially Equivalent on 2004-10-22. Applicant: DePuy Orthopaedics, Inc.. Device class: 1.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KIH
Device class: Class 1
Regulation: 21 CFR 888.4200
Advisory panel: Orthopedic
Date received: 2004-09-23
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.