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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 K121670
Device Name MEDYSSEY CANNULATED PEDICLE SCREW
Applicant
MEDYSSEY CO., LTD.
8001 N. LINCOLN AVE
SUITE 401
SKOKIE,  IL  60077
Applicant Contact MICHAEL KVITNITSKY
Correspondent
MEDYSSEY CO., LTD.
8001 N. LINCOLN AVE
SUITE 401
SKOKIE,  IL  60077
Correspondent Contact MICHAEL KVITNITSKY
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/06/2012
Decision Date 01/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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