Valkyrie Thoracic Fixation System

Plate, Fixation, Bone

JM Longyear Manufacturing, LLC D/b/a Able Medical Devices

The following data is part of a premarket notification filed by Jm Longyear Manufacturing, Llc D/b/a Able Medical Devices with the FDA for Valkyrie Thoracic Fixation System.

Pre-market Notification Details

Device IDK211695
510k NumberK211695
Device Name:Valkyrie Thoracic Fixation System
ClassificationPlate, Fixation, Bone
Applicant JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn,  MI  49841
ContactWade Depas
CorrespondentWade Depas
JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn,  MI  49841
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-02
Decision Date2021-06-23

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