INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP— 510(k) K113570

Substantially Equivalent

Integra Burlington Ma, Inc.

FDA 510(k) clearance K113570 for INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP, Substantially Equivalent on 2012-02-22. Applicant: Integra Burlington Ma, Inc..

Clearance details

Applicant: Integra Burlington Ma, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2011-12-02
Decision date: 2012-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.