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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 K132732
Device Name MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
Applicant
Medyssey USA, Inc.
1550 E. Higgins Rd.
Suite 123
Elk Grove Village,  IL  60007
Applicant Contact JOHN KUCZYNSKI
Correspondent
Medyssey USA, Inc.
1550 E. Higgins Rd.
Suite 123
Elk Grove Village,  IL  60007
Correspondent Contact JOHN KUCZYNSKI
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/03/2013
Decision Date 07/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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