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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K121670
Device Name MEDYSSEY CANNULATED PEDICLE SCREW
Original Applicant
MEDYSSEY CO., LTD.
8001 n. lincoln ave
suite 401
skokie,  IL  60077
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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