VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0— 510(k) K193423

Substantially Equivalent

Icotec AG

FDA 510(k) clearance K193423 for VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0, Substantially Equivalent on 2020-05-22. Applicant: Icotec AG.

Clearance details

Applicant: Icotec AG
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2019-12-09
Decision date: 2020-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 9450 Altstaetten (Sg), CH

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.