KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set— 510(k) K171938

Substantially Equivalent

Medtronic

FDA 510(k) clearance K171938 for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set, Substantially Equivalent on 2017-10-23. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2017-06-28
Decision date: 2017-10-23
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.