JACE Medical Thoracic Plating System

Plate, Fixation, Bone

JACE Medical, LLC

The following data is part of a premarket notification filed by Jace Medical, Llc with the FDA for Jace Medical Thoracic Plating System.

Pre-market Notification Details

Device IDK210290
510k NumberK210290
Device Name:JACE Medical Thoracic Plating System
ClassificationPlate, Fixation, Bone
Applicant JACE Medical, LLC 3516 Commerce Drive Warsaw,  IN  46850
ContactScott Steffensmeier
CorrespondentDawn N. Norman
MRC Global 9085 E. Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-02
Decision Date2021-04-30

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