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FDA 510(k)

Artus™ cervical plate system

K-Number: K202227 · 2020-09-14

ApplicantUlrich GmbH & Co. KG
Decision Date2020-09-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Artus™ cervical plate system is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K202227. 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 Artus™ cervical plate system?

Artus™ cervical plate system is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K202227.

When did Artus™ cervical plate system receive FDA 510(k) clearance?

Artus™ cervical plate system received FDA 510(k) clearance on 2020-09-14, under 510(k) number K202227.

Who is the listed applicant for Artus™ cervical plate system?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artus™ cervical plate system?

The FDA product code for Artus™ cervical plate system is KWQ.

Other records listing Ulrich GmbH & Co. KG 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.

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K251295ulrichINJECT CT Motion (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motionK192872ulrichINJECT CT Motion

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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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