VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM— 510(k) K123906

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K123906 for VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM, Substantially Equivalent on 2013-04-01. Applicant: Medtronic Sofamor Danek USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2012-12-19
Decision date: 2013-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.