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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 K142752
Device Name Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Applicant Contact DONNA M. SEMLAK
Correspondent
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439
Correspondent Contact DONNA M. SEMLAK
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received09/24/2014
Decision Date 06/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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