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 Simpact Sacroiliac Joint Fixation System.

Pre-market Notification Details

Device IDK212903
510k NumberK212903
Device Name: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 Received2021-09-13
Decision Date2021-12-15

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