TOPEZ TOTAL ANKLE REPLACEMENT— 510(k) K051023

Substantially Equivalent

Topez Orthopedics, Inc.

FDA 510(k) clearance K051023 for TOPEZ TOTAL ANKLE REPLACEMENT, Substantially Equivalent on 2005-11-15. Applicant: Topez Orthopedics, Inc..

Clearance details

Applicant: Topez Orthopedics, Inc.
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2005-04-22
Decision date: 2005-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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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.