510(k) K091302— INTEGRA MOZAIK AND OS MOLDABLE MORSELS

Substantially Equivalent

Integra LifeSciences Corporation

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2009-05-04
Decision date: 2009-12-04
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, 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.