Lever Action Plate System

Plate, Fixation, Bone

McGinley Orthpaedic Innovations, LLC

The following data is part of a premarket notification filed by Mcginley Orthpaedic Innovations, Llc with the FDA for Lever Action Plate System.

Pre-market Notification Details

Device IDK200834
510k NumberK200834
Device Name:Lever Action Plate System
ClassificationPlate, Fixation, Bone
Applicant McGinley Orthpaedic Innovations, LLC 2435 King Boulevard #230 Casper,  WY  82604
ContactAdam M. Johnson
CorrespondentDavid Mcgurl
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-06-25

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