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FDA 510(k)

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

K-Number: K190545 · 2019-06-20

ApplicantIcotec AG
Decision Date2019-06-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2019-06-20 under approval number K190545. 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® one Pedicle System MIS and LightMore® Pedicle System 6.0?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Icotec AG. The 510(k) number is K190545.

When was VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 approved by the FDA?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 received FDA 510(k) clearance on 2019-06-20, under approval number K190545.

What company makes VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is manufactured by Icotec AG.

What is the FDA product code for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

The FDA product code for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is NKB.

Related Clinical Trials

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Other Devices by Icotec AG

K151977icotec Pedicle System K172480icotec Interbody Cage System K201587icotec Anterior Cervical Plate System K200596G21 Cement, VADER® Pedicle System K200235KONG-TL VBR System, KONG-C VBR System K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

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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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