SOVEREIGN SPINAL SYSTEM— 510(k) K110063

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K110063 for SOVEREIGN SPINAL SYSTEM, Substantially Equivalent on 2011-10-04. Applicant: Medtronic Sofamor Danek, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2011-01-10
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.