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FDA 510(k)

Zavation Buttress Plate System

K-Number: K180537 · 2018-03-27

ApplicantZavation Medical Products, LLC
Decision Date2018-03-27
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation Buttress 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 2018-03-27 under 510(k) number K180537. 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 Zavation Buttress Plate System?

Zavation Buttress Plate System is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K180537.

When did Zavation Buttress Plate System receive FDA 510(k) clearance?

Zavation Buttress Plate System received FDA 510(k) clearance on 2018-03-27, under 510(k) number K180537.

Who is the listed applicant for Zavation Buttress 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 Zavation Buttress Plate System?

The FDA product code for Zavation Buttress 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.

K253943Tiger 2 SystemK243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK223808Zavation Navigation Instrument SystemK230731Zavation ALIF System

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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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