Tarsa-Link Stand-Alone Wedge Fixation System

Plate, Fixation, Bone

LIFE SPINE INC.

The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Tarsa-link Stand-alone Wedge Fixation System.

Pre-market Notification Details

Device IDK161037
510k NumberK161037
Device Name:Tarsa-Link Stand-Alone Wedge Fixation System
ClassificationPlate, Fixation, Bone
Applicant LIFE SPINE INC. 13951 S QUALITY DRIVE Huntley,  IL  60142
ContactRandy Lewis
CorrespondentRandy Lewis
LIFE SPINE INC. 13951 S QUALITY DRIVE Huntley,  IL  60142
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-13
Decision Date2016-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00190837022518 K161037 000

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