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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K240515
Device Name uNion® MAX Cervical Plate System
Applicant
Ulrich Medical USA, Inc.
3700 E Plano Pkwy.
Suite 200
Plano,  TX  75074
Applicant Contact Eric Lucas
Correspondent
Ulrich Medical USA, Inc.
3700 E Plano Pkwy.
Suite 200
Plano,  TX  75074
Correspondent Contact Eric Lucas
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/23/2024
Decision Date 03/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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