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FDA 510(k)

Z-Span Plate System

K-Number: K160362 · 2016-03-22

ApplicantZavation, LLC
Decision Date2016-03-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z-Span Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2016-03-22 under 510(k) 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. The listed applicant is Zavation, LLC. The 510(k) number is K160362.

When did Z-Span Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Z-Span Plate System?

The FDA 510(k) record lists Zavation, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Zavation, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162206Zavation IBFK162575Z-LINKPC SystemK162824Z-Span Plate SystemK161016Z-Clamp ISP SystemK153404Zavation Spinal System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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