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.
|Device Name:||Valkyrie Thoracic Fixation System|
|Classification||Plate, Fixation, Bone|
|Applicant||JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn, MI 49841|
JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn, MI 49841
|CFR Regulation Number||888.3030 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|