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FDA 510(k)

Cervical Plate System

K-Number: K223753 · 2023-03-14

ApplicantDouble Medical Technology, Inc.
Decision Date2023-03-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Plate System is a medical device manufactured by Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-03-14 under approval number K223753. 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 System?

Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Double Medical Technology, Inc.. The 510(k) number is K223753.

When was Cervical Plate System approved by the FDA?

Cervical Plate System received FDA 510(k) clearance on 2023-03-14, under approval number K223753.

What company makes Cervical Plate System?

Cervical Plate System is manufactured by Double Medical Technology, Inc..

What is the FDA product code for Cervical Plate System?

The FDA product code for Cervical Plate System is KWQ.

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Other Devices by Double Medical Technology, Inc.

K151458Double Medical Universal Spine System K172830Double Medical Femoral Nail System K172828Double Medical Cage System K221221Advanced Intramedullary Nail System K220921Metal Bone Screw K233078Posterior Cervical Spine System

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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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