CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems— 510(k) K160879

Substantially Equivalent

Medos International Sàrl

FDA 510(k) clearance K160879 for CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Substantially Equivalent on 2016-12-20. Applicant: Medos International Sàrl.

Clearance details

Applicant: Medos International Sàrl
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2016-03-30
Decision date: 2016-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lelocle, CH

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.