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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 K232218
Device Name Zenius™ Spinal System
Applicant
Medyssey USA, Inc.
43176 Business Park Dr. Suite 107
Temecula,  CA  92590
Applicant Contact Youngsu Jang
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Kyle Kovach
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/26/2023
Decision Date 08/24/2023
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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