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FDA 510(k)

VADER® Pedicle System

K-Number: K232628 · 2024-02-26

ApplicantIcotec AG
Decision Date2024-02-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VADER® Pedicle System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2024-02-26 under approval number K232628. 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?

VADER® Pedicle System is a medical device that received FDA 510(k) clearance on 2024-02-26. It is manufactured by Icotec AG. The 510(k) number is K232628.

When was VADER® Pedicle System approved by the FDA?

VADER® Pedicle System received FDA 510(k) clearance on 2024-02-26, under approval number K232628.

What company makes VADER® Pedicle System?

VADER® Pedicle System is manufactured by Icotec AG.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Icotec AG

K151977icotec Pedicle System K172480icotec Interbody Cage System K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 K201587icotec Anterior Cervical Plate System K200596G21 Cement, VADER® Pedicle System K200235KONG-TL VBR System, KONG-C VBR System

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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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