MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS— 510(k) K072208
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K072208 for MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS, Substantially Equivalent on 2007-09-07. Applicant: Integra LifeSciences Corporation.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code HBL
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Planisboro, NJ, US
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
Source: openFDA MAUDE database, through . 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.