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FDA 510(k)

VADER® Pedicle System and VADER®one Pedicle System

K-Number: K242900 · 2025-02-27

ApplicantIcotec AG
Decision Date2025-02-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VADER® Pedicle System and VADER®one Pedicle System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2025-02-27 under approval number K242900. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VADER® Pedicle System and VADER®one Pedicle System?

VADER® Pedicle System and VADER®one Pedicle System is a medical device that received FDA 510(k) clearance on 2025-02-27. It is manufactured by Icotec AG. The 510(k) number is K242900.

When was VADER® Pedicle System and VADER®one Pedicle System approved by the FDA?

VADER® Pedicle System and VADER®one Pedicle System received FDA 510(k) clearance on 2025-02-27, under approval number K242900.

What company makes VADER® Pedicle System and VADER®one Pedicle System?

VADER® Pedicle System and VADER®one Pedicle System is manufactured by Icotec AG.

What is the FDA product code for VADER® Pedicle System and VADER®one Pedicle System?

The FDA product code for VADER® Pedicle System and VADER®one Pedicle System is NKB.

Related Clinical Trials

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Other Devices by Icotec AG

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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