KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set— 510(k) K152604

Substantially Equivalent

Medtronic Sofamor Danek USA, Incorporated

FDA 510(k) clearance K152604 for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Substantially Equivalent on 2016-01-06. Applicant: Medtronic Sofamor Danek USA, Incorporated.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Incorporated
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2015-09-11
Decision date: 2016-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PML

product code PML

Death: 8
Total: 8

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.