INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP— 510(k) K141841
Substantially EquivalentIntegra Lifescience Corportation
FDA 510(k) clearance K141841 for INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP, Substantially Equivalent on 2014-08-01. Applicant: Integra Lifescience Corportation.
Clearance details
- Applicant
- Integra Lifescience Corportation
- Product code
- Code MQV
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Planisboro, NJ, US
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.