T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE— 510(k) K131888

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K131888 for T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE, Substantially Equivalent on 2013-09-23. Applicant: Medtronic Sofamor Danek, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2013-06-25
Decision date: 2013-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.