Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set— 510(k) K191148

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K191148 for Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set, Substantially Equivalent on 2019-09-12. Applicant: Medtronic Sofamor Danek USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2019-04-30
Decision date: 2019-09-12
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.