INTEGRA(TM) CUSA NXT(TM) BONE TIPS— 510(k) K111741

Substantially Equivalent

Integra Burlington Ma, Inc. (Formerly Integra Radi

FDA 510(k) clearance K111741 for INTEGRA(TM) CUSA NXT(TM) BONE TIPS, Substantially Equivalent on 2011-08-23. Applicant: Integra Burlington Ma, Inc. (Formerly Integra Radi.

Clearance details

Applicant: Integra Burlington Ma, Inc. (Formerly Integra Radi
Product code: Code LFL
Advisory panel: Unknown
Date received: 2011-06-21
Decision date: 2011-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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.