Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System— 510(k) K192818

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K192818 for Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System, Substantially Equivalent on 2020-03-31. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2019-10-01
Decision date: 2020-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, 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.