INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP— 510(k) K141841

Substantially Equivalent

Integra 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
Download summary PDFView on FDA.gov ↗

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.