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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 K121671
Device Name PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Applicant
ZIMMER SPINE, INC.
7375 Bush Lake Rd
Minneapolis,  MN  55439
Applicant Contact DAVID PADGETT
Correspondent
ZIMMER SPINE, INC.
7375 Bush Lake Rd
Minneapolis,  MN  55439
Correspondent 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 (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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