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FDA 510(k)

uNion® MAX Cervical Plate System

K-Number: K240515 · 2024-03-18

ApplicantUlrich Medical USA, Inc.
Decision Date2024-03-18
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

uNion® MAX Cervical Plate System is a medical device manufactured by Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2024-03-18 under approval number K240515. 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 uNion® MAX Cervical Plate System?

uNion® MAX Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-03-18. It is manufactured by Ulrich Medical USA, Inc.. The 510(k) number is K240515.

When was uNion® MAX Cervical Plate System approved by the FDA?

uNion® MAX Cervical Plate System received FDA 510(k) clearance on 2024-03-18, under approval number K240515.

What company makes uNion® MAX Cervical Plate System?

uNion® MAX Cervical Plate System is manufactured by Ulrich Medical USA, Inc..

What is the FDA product code for uNion® MAX Cervical Plate System?

The FDA product code for uNion® MAX Cervical Plate System is KWQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Ulrich Medical USA, Inc.

K241396uCerv Flux™-C 3D Porous Titanium Cervical Interbody K251719Momentum® Posterior Spinal Fixation System K252087Navigation Module of the Cortium® System

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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