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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 K121671
Model 3500 SERIES
Device Name PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Original Applicant
ZIMMER SPINE, INC.
7375 bush lake rd
minneapolis,  MN  55439
Original Contact david padgett
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/06/2012
Decision Date 07/18/2012
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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