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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K161637
Device Name Poseidon OCT Spinal Fixation 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
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact Rich Jansen, Pharm.D.
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received06/14/2016
Decision Date 01/05/2017
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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