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510(k) Data Aggregation
K Number
K202889Device Name
Able Medical Devices Valkyrie Thoracic Fixation System
Manufacturer
JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Date Cleared
2021-03-02
(155 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Valkyrie Thoracic Fixation System is intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
Device Description
The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in 3.0mm and 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK-Optima™ per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.
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