Life Spine SIMPACT Sacroiliac Joint Fixation System

Sacroiliac Joint Fixation

Life Spine Inc.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Simpact Sacroiliac Joint Fixation System.

Pre-market Notification Details

Device IDK201538
510k NumberK201538
Device Name:Life Spine SIMPACT Sacroiliac Joint Fixation System
ClassificationSacroiliac Joint Fixation
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 CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-09-18

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