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FDA 510(k)

Xenco Medical Multilevel CerviKit

K-Number: K213456 · 2021-12-21

ApplicantXenco Medical, LLC
Decision Date2021-12-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical Multilevel CerviKit is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213456. 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 Xenco Medical Multilevel CerviKit?

Xenco Medical Multilevel CerviKit is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Xenco Medical, LLC. The 510(k) number is K213456.

When did Xenco Medical Multilevel CerviKit receive FDA 510(k) clearance?

Xenco Medical Multilevel CerviKit received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213456.

Who is the listed applicant for Xenco Medical Multilevel CerviKit?

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

What is the FDA product code for Xenco Medical Multilevel CerviKit?

The FDA product code for Xenco Medical Multilevel CerviKit is KWQ.

Other records listing Xenco Medical, 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.

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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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