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FDA 510(k)

Z-Span Plate System

K-Number: K202624 · 2020-11-04

ApplicantZavation Medical Products, LLC
Decision Date2020-11-04
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 Medical Products, LLC. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K202624. 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 2020-11-04. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K202624.

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

Z-Span Plate System received FDA 510(k) clearance on 2020-11-04, under 510(k) number K202624.

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

The FDA 510(k) record lists Zavation Medical Products, 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 Medical Products, 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.

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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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