FIXATE TISSUE BAND— 510(k) K113400

Substantially Equivalent

Anulex Technologies, Inc.

FDA 510(k) clearance K113400 for FIXATE TISSUE BAND, Substantially Equivalent on 2011-12-16. Applicant: Anulex Technologies, Inc..

Clearance details

Applicant: Anulex Technologies, Inc.
Product code: Code GZB
Advisory panel: Neurology
Date received: 2011-11-17
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.