FUSION— 510(k) K061912

Substantially Equivalent

Burke, Inc.

FDA 510(k) clearance K061912 for FUSION, Substantially Equivalent on 2006-08-01. Applicant: Burke, Inc..

Clearance details

Applicant: Burke, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2006-07-06
Decision date: 2006-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, KS, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.