The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System— 510(k) K193067

Name: FDA 510(k) clearance K193067
Creator: U.S. Food and Drug Administration
Published: 2020-06-08

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K193067 for The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System, Substantially Equivalent on 2020-06-08. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HSN
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2019-11-04
Decision date: 2020-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.