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FDA 510(k)

icotec Pedicle System

K-Number: K151977 · 2016-04-12

ApplicantIcotec AG
Decision Date2016-04-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

icotec Pedicle System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2016-04-12 under approval number K151977. 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 icotec Pedicle System?

icotec Pedicle System is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by Icotec AG. The 510(k) number is K151977.

When was icotec Pedicle System approved by the FDA?

icotec Pedicle System received FDA 510(k) clearance on 2016-04-12, under approval number K151977.

What company makes icotec Pedicle System?

icotec Pedicle System is manufactured by Icotec AG.

What is the FDA product code for icotec Pedicle System?

The FDA product code for icotec Pedicle System is NKB.

Related Clinical Trials

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Other Devices by Icotec AG

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 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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