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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K233375
Device Name Tranquil-L Interbody 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 Number888.3080
Classification Product Code
MAX  
Date Received10/02/2023
Decision Date 03/20/2024
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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