Pantheon Medical Balanced Plating System

Plate, Fixation, Bone

PANTHEON MEDICAL

The following data is part of a premarket notification filed by Pantheon Medical with the FDA for Pantheon Medical Balanced Plating System.

Pre-market Notification Details

Device IDK162154
510k NumberK162154
Device Name:Pantheon Medical Balanced Plating System
ClassificationPlate, Fixation, Bone
Applicant PANTHEON MEDICAL 1505 FEDERAL ST, #300 Dallas,  TX  75201
ContactTravid Bird
CorrespondentLee Strnad
INTREPID ORTHOPEDICS, LLC 3046 BRECKSVILLE ROAD SUITE 4 Richfield,  OH  44286
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-02
Decision Date2017-04-24
Summary:summary

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