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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K183409
Device Name Athena II Cervical Plate System
Applicant
Medyssey USA, Inc.
1550 E. Higgins Rd.
Suite 123
Elk Grove Village,  IL  60007
Applicant Contact Shawn Kim
Correspondent
Silver Pine Consulting, LLC
3851 Mossy Oak Dr.
Fort Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/10/2018
Decision Date 02/11/2019
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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