CUSA NXT EXTENDED LENGTH TIP— 510(k) K102258

Substantially Equivalent

Integra Radionics, Inc.

FDA 510(k) clearance K102258 for CUSA NXT EXTENDED LENGTH TIP, Substantially Equivalent on 2011-06-10. Applicant: Integra Radionics, Inc..

Clearance details

Applicant: Integra Radionics, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2010-08-10
Decision date: 2011-06-10
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.