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FDA 510(k)

CarboClear® Cervical Plate System

K-Number: K200883 · 2020-06-04

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2020-06-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear® Cervical Plate System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-06-04 under approval number K200883. 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 CarboClear® Cervical Plate System?

CarboClear® Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-06-04. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K200883.

When was CarboClear® Cervical Plate System approved by the FDA?

CarboClear® Cervical Plate System received FDA 510(k) clearance on 2020-06-04, under approval number K200883.

What company makes CarboClear® Cervical Plate System?

CarboClear® Cervical Plate System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for CarboClear® Cervical Plate System?

The FDA product code for CarboClear® Cervical Plate System is KWQ.

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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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