Life Spine Lumbar Fixation System (SENTRY)

Appliance, Fixation, Spinal Intervertebral Body

Life Spine, Inc.

The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Life Spine Lumbar Fixation System (sentry).

Pre-market Notification Details

Device IDK180166
510k NumberK180166
Device Name:Life Spine Lumbar Fixation System (SENTRY)
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Life Spine, Inc. 13951 S Quality Drive Huntley,  IL  60142
ContactRandy Lewis
CorrespondentAngela Batker
Life Spine, Inc. 13951 S Quality Drive Huntley,  IL  60142
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-22
Decision Date2018-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00190837034597 K180166 000

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