Ghost Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Life Spine, Inc.

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

Pre-market Notification Details

Device IDK213417
510k NumberK213417
Device Name:Ghost Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Life Spine, Inc. 13951 S. Quality Drive Huntley,  IL  60142
ContactAngela Batker
CorrespondentAngela Batker
Life Spine, Inc. 13951 S. Quality Drive Huntley,  IL  60142
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-20
Decision Date2022-09-29

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