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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 the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) 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. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K223753.

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

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

Who is the listed applicant for Cervical Plate System?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Plate System?

The FDA product code for Cervical Plate System is KWQ.

Other records listing Double Medical Technology, Inc. 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.

K252729Universal Spinal SystemK242348Locking Screw,CoCrMoK233078Posterior Cervical Spine SystemK221150Advanced Bone PlateK221088Anatomic Bone PlateK221090Metal Cannulated Screw

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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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