FDA 510(k)

Z-Span Plate System

K-Number: K160362 · 2016-03-22

Decision Date2016-03-22

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Z-Span Plate System is a medical device manufactured by Zavation, LLC. It received FDA 510(k) clearance on 2016-03-22 under approval number K160362. 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 Z-Span Plate System?

Z-Span Plate System is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Zavation, LLC. The 510(k) number is K160362.

When was Z-Span Plate System approved by the FDA?

Z-Span Plate System received FDA 510(k) clearance on 2016-03-22, under approval number K160362.

What company makes Z-Span Plate System?

Z-Span Plate System is manufactured by Zavation, LLC.

What is the FDA product code for Z-Span Plate System?

The FDA product code for Z-Span Plate System is KWQ.

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Other Devices by Zavation, LLC

K161016Z-Clamp ISP System K153404Zavation Spinal System K162206Zavation IBF K162575Z-LINKPC System K162824Z-Span Plate System

Related Devices (Code: KWQ)

K160982SphynxEden 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

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