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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K121320
Device Name C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
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 Number888.3080
Classification Product Code
ODP  
Date Received05/02/2012
Decision Date 08/10/2012
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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