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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K223529
Device Name PressON Spinal Fixation System
Applicant
Nexus Spine, LLC
2825 E. Cottonwood Pkwy.
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 Number888.3070
Classification Product Code
NKB  
Date Received11/23/2022
Decision Date 05/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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