MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

US SPINE

The following data is part of a premarket notification filed by Us Spine with the FDA for Modification To Preference Pedicle Screw System.

Pre-market Notification Details

Device IDK081883
510k NumberK081883
Device Name:MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant US SPINE 13540 GUILD AVE Apple Valley,  MN  55124
ContactRichard Jansen
CorrespondentRichard Jansen
US SPINE 13540 GUILD AVE Apple Valley,  MN  55124
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-02
Decision Date2008-09-24
Summary:summary

NIH GUDID Devices

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