SOLSTICE OCT System

Appliance, Fixation, Spinal Interlaminal

LIFE SPINE, INC

The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Solstice Oct System.

Pre-market Notification Details

Device IDK142253
510k NumberK142253
Device Name:SOLSTICE OCT System
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates,  IL  60169
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE, INC 13951 South Quality Drive Huntley,  IL  60142
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-14
Decision Date2015-04-23
Summary:summary

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