ATLANTIK— 510(k) K070794

Substantially Equivalent

Medical Biomat

FDA 510(k) clearance K070794 for ATLANTIK, Substantially Equivalent on 2007-07-10. Applicant: Medical Biomat.

Clearance details

Applicant: Medical Biomat
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2007-03-22
Decision date: 2007-07-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Vaulx-En-Velin, Lyon, FR

Download summary PDF View on FDA.gov ↗

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.