Iliad Pedicle Screw System and Zenius Pedicle Screw System— 510(k) K142835

Substantially Equivalent

Medyssey USA, Inc.

FDA 510(k) clearance K142835 for Iliad Pedicle Screw System and Zenius Pedicle Screw System, Substantially Equivalent on 2015-06-12. Applicant: Medyssey USA, Inc..

Clearance details

Applicant: Medyssey USA, Inc.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2014-09-30
Decision date: 2015-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.