PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW 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 Pathfinder Nxt Minimally Invasive Pedicle Screw System.

Pre-market Notification Details

Device IDK132884
510k NumberK132884
Device Name:PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-13
Decision Date2013-11-25
Summary:summary

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