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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 K223627
Device Name PreView-III™ Anterior Cervical Plate System
Applicant
Nexus Spine, LLC
2825 East Cottonwood Parkway Suite 330
Salt Lake City,  UT  84121
Applicant Contact Jared Crocker
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/05/2022
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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