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FDA 510(k)

ZION Anterior Cervical Fixation System

K-Number: K160702 · 2016-08-23

ApplicantAstura Medical
Decision Date2016-08-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZION Anterior Cervical Fixation System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2016-08-23 under approval number K160702. 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 ZION Anterior Cervical Fixation System?

ZION Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2016-08-23. It is manufactured by Astura Medical. The 510(k) number is K160702.

When was ZION Anterior Cervical Fixation System approved by the FDA?

ZION Anterior Cervical Fixation System received FDA 510(k) clearance on 2016-08-23, under approval number K160702.

What company makes ZION Anterior Cervical Fixation System?

ZION Anterior Cervical Fixation System is manufactured by Astura Medical.

What is the FDA product code for ZION Anterior Cervical Fixation System?

The FDA product code for ZION Anterior Cervical Fixation System is KWQ.

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Other Devices by Astura Medical

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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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