Certas Plus Programmable Valves— 510(k) K223330
Substantially EquivalentIntegra Lifesciences Production Corporation
FDA 510(k) clearance K223330 for Certas Plus Programmable Valves, Substantially Equivalent on 2023-02-01. Applicant: Integra Lifesciences Production Corporation.
Clearance details
- Applicant
- Integra Lifesciences Production Corporation
- Product code
- Code JXG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
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.