Vitality Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

ZIMMER SPINE, INC.

The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Vitality Spinal Fixation System.

Pre-market Notification Details

Device IDK150896
510k NumberK150896
Device Name:Vitality Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439
ContactDonna M. Semlak
CorrespondentJonathan Gilbert
ZIMMER SPINE, INC. 7375 BUSH LAKE ROAD Minneapolis,  MN  55439
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-02
Decision Date2015-08-31
Summary:summary

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