MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT— 510(k) K131673

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K131673 for MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT, Substantially Equivalent on 2013-10-03. Applicant: Medtronic Sofamor Danek USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2013-06-07
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.