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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 K133086
Device Name TITLE 2 POLYAXIAL SPINAL SYSTEM
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Applicant Contact MICHELLE LENZ
Correspondent
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Correspondent Contact MICHELLE LENZ
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received09/30/2013
Decision Date 11/27/2013
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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