AdvantageRib System

Plate, Fixation, Bone

SIG Medical Corporation

The following data is part of a premarket notification filed by Sig Medical Corporation with the FDA for Advantagerib System.

Pre-market Notification Details

Device IDK183317
510k NumberK183317
Device Name:AdvantageRib System
ClassificationPlate, Fixation, Bone
Applicant SIG Medical Corporation 238 East Chocolate Avenue, Suite 2 Hershey,  PA  17033
ContactAndrew Davison
CorrespondentLauren Smith
JALEX Medical, LLC. 30311 Clemens Road, Suite #5D Westlake,  OH  44145
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-30
Decision Date2019-02-14
Summary:summary

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