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510(k) K202889

Able Medical Devices Valkyrie Thoracic Fixation System by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
September 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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