MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114— 510(k) K090506

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K090506 for MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114, Substantially Equivalent on 2009-04-20. Applicant: Integra LifeSciences Corporation.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code HBL
Advisory panel: Neurology
Date received: 2009-02-25
Decision date: 2009-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.