K191148

Substantially Equivalent

Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set

Applicant: Medtronic Sofamor Danek USA, Inc.
Product 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

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.