MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)— 510(k) K123691

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K123691 for MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM), Substantially Equivalent on 2013-01-31. Applicant: Medtronic Sofamor Danek, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2012-12-03
Decision date: 2013-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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.