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 ID | K211695 |
510k Number | K211695 |
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 |
Contact | Wade Depas |
Correspondent | Wade Depas JM Longyear Manufacturing, LLC D/b/a Able Medical Devices 512 4th Street Gwinn, MI 49841 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-02 |
Decision Date | 2021-06-23 |