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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 K170964
Device Name Zenius Spinal System
Applicant
Medyssey USA, Inc.
1550 E. Higgins Rd.
Suite 123
Elk Grove Village,  IL  60007
Applicant Contact Shawn Kim
Correspondent
Mrc-X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Christine Scifert, MS, MEM
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/31/2017
Decision Date 04/26/2017
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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