INFINITY TOTAL ANKLE SYSTEM— 510(k) K123954

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K123954 for INFINITY TOTAL ANKLE SYSTEM, Substantially Equivalent on 2013-04-01. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2012-12-21
Decision date: 2013-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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.