LEFORTE SYSTEM BONE PLATE & SCREW

Plate, Bone

ARKIN CONSULTING GROUP

The following data is part of a premarket notification filed by Arkin Consulting Group with the FDA for Leforte System Bone Plate & Screw.

Pre-market Notification Details

Device IDK112457
510k NumberK112457
Device Name:LEFORTE SYSTEM BONE PLATE & SCREW
ClassificationPlate, Bone
Applicant ARKIN CONSULTING GROUP 1733 CANTON LANE Marietta,  GA  30062 -2679
ContactPaul Sumner
CorrespondentPaul Sumner
ARKIN CONSULTING GROUP 1733 CANTON LANE Marietta,  GA  30062 -2679
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-26
Decision Date2012-05-18
Summary:summary

NIH GUDID Devices

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