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FDA 510(k)

icotec Anterior Cervical Plate System

K-Number: K233215 · 2024-05-17

ApplicantIcotec AG
Decision Date2024-05-17
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 2024-05-17 under approval number K233215. 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 2024-05-17. It is manufactured by Icotec AG. The 510(k) number is K233215.

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

icotec Anterior Cervical Plate System received FDA 510(k) clearance on 2024-05-17, under approval number K233215.

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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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: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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