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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 K181978
Device Name Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
Applicant
Medyssey USA, Inc.
1550 E. Higgins Rd.
Suite 123
Elk Grove Village,  IL  60007
Applicant Contact Shawn Kim
Correspondent
Musculoskeletal Clinical Reulatory Advisers, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Margeaux Rogers
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/24/2018
Decision Date 08/13/2018
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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