FDA 510(k)

Cervical Plate

K-Number: K190565 · 2019-05-31

Decision Date2019-05-31

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cervical Plate is the device name listed in this FDA 510(k) record. The listed applicant is Eisertech, LLC. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190565. 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 Cervical Plate?

Cervical Plate is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Eisertech, LLC. The 510(k) number is K190565.

When did Cervical Plate receive FDA 510(k) clearance?

Cervical Plate received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190565.

Who is the listed applicant for Cervical Plate?

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

What is the FDA product code for Cervical Plate?

The FDA product code for Cervical Plate is KWQ.

Other records listing Eisertech, 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.

K192768Temporary Fixation Pins

Related Devices (Code: KWQ)

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES 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, LLC K260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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.