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FDA 510(k)

Cervical Plate

K-Number: K190565 · 2019-05-31

ApplicantEisertech, LLC
Decision Date2019-05-31
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Plate is a medical device manufactured by Eisertech, LLC. It received FDA 510(k) clearance on 2019-05-31 under approval 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. It is manufactured by Eisertech, LLC. The 510(k) number is K190565.

When was Cervical Plate approved by the FDA?

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

What company makes Cervical Plate?

Cervical Plate is manufactured by Eisertech, LLC.

What is the FDA product code for Cervical Plate?

The FDA product code for Cervical Plate is KWQ.

Other Devices by Eisertech, LLC

K192768Temporary Fixation Pins

Related Devices (Code: KWQ)

K160982Sphynx™Eden 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

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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