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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 K150896
Device Name Vitality Spinal Fixation System
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Applicant Contact DONNA M. SEMLAK
Correspondent
ZIMMER SPINE, INC.
7375 BUSH LAKE ROAD
MINNEAPOLIS,  MN  55439
Correspondent Contact Jonathan Gilbert
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received04/02/2015
Decision Date 08/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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