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FDA 510(k)

icotec Anterior Cervical Plate System

K-Number: K201587 · 2020-10-15

ApplicantIcotec AG
Decision Date2020-10-15
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

icotec Anterior Cervical Plate System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2020-10-15 under approval number K201587. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the icotec Anterior Cervical Plate System?

icotec Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Icotec AG. The 510(k) number is K201587.

When was icotec Anterior Cervical Plate System approved by the FDA?

icotec Anterior Cervical Plate System received FDA 510(k) clearance on 2020-10-15, under approval number K201587.

What company makes icotec Anterior Cervical Plate System?

icotec Anterior Cervical Plate System is manufactured by Icotec AG.

What is the FDA product code for icotec Anterior Cervical Plate System?

The FDA product code for icotec Anterior Cervical Plate System is KWQ.

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Official Source

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