AGILITY LP TOTAL ANKLE PROSTHESIS— 510(k) K053569

Name: FDA 510(k) clearance K053569
Creator: U.S. Food and Drug Administration
Published: 2006-03-31

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K053569 for AGILITY LP TOTAL ANKLE PROSTHESIS, Substantially Equivalent on 2006-03-31. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code HSN
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2005-12-22
Decision date: 2006-03-31
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 HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

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.