CD HORIZON SPINAL SYSTEM— 510(k) K132111

Substantially Equivalent

Medtronic Sofamor Danek USA

FDA 510(k) clearance K132111 for CD HORIZON SPINAL SYSTEM, Substantially Equivalent on 2013-08-06. Applicant: Medtronic Sofamor Danek USA.

Clearance details

Applicant: Medtronic Sofamor Danek USA
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2013-07-09
Decision date: 2013-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.