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FDA 510(k)

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

K-Number: K162194 · 2016-12-08

ApplicantMedicrea International SA
Decision Date2016-12-08
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2016-12-08 under approval number K162194. 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 MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System?

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Medicrea International SA. The 510(k) number is K162194.

When was MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System approved by the FDA?

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System received FDA 510(k) clearance on 2016-12-08, under approval number K162194.

What company makes MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System?

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is manufactured by Medicrea International SA.

What is the FDA product code for MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System?

The FDA product code for MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System is KWQ.

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Related PubMed Literature

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc. K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC

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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